Versatility, flexibility, and simplicity
The Mergence-S System is a universal system of implant-specific instrumentation used for site preparation, size trialing and implant insertion.
The Mergence-S System is designed to aid in the implantation of ZimVie Spine’s TM-S Cervical Fusion Device, Vista®-S, Puros®-S and Puros®-S2 Cervical Interbody Allograft Implants. The Smith-Robinson surgical technique is used with standard instruments, except those specifically related to the sizing and insertion of each interbody device
- Mergence-S is designed to work with many of ZimVie Spine’s interbody options.
- Three different inserter options afford surgeon choice to facilitate comfort.
- Expanded options of trials and rasps accommodate patient anatomy.
- Instrumentation within the Mergence-S System is color-coded by footprint and lordosis angle to allow for easy selection.
- Interbodies easily attach to the inserters, cutting back on unnecessary steps and potentially reducing OR time.
ZimVie Spine’s anterior cervical plate products are engineered to treat complex cases with clinical effectiveness, always with a commitment to patient safety.
The instrument(s) is designed for use in orthopedic procedures. These instruments were carefully designed as surgical instruments and extreme care should be taken to ensure that the instrument(s) are in good working order. All applicable surgical techniques and instructions for instruments should be carefully read and followed. Some instruments supplied with this package insert are intended for single use only; refer to product label to determine if the instrument is intended for single use only. ZimVie Spine instruments are made out of a variety of materials commonly used in orthopedic procedures. Materials include stainless steels with and without titanium aluminum nitride surface, polymers, aluminum alloy and titanium. No warranties, expressed or implied, are made.
The instrument(s) is indicated for general surgical use in orthopedic procedures.
This does not identify specific procedural contraindications because the instrument(s) is intended for general surgical use. General use contraindications include:
- Local inflammation
- Misuse of the instrument may inhibit or prevent proper functioning and may cause injury to the patient or operator.
- Do not use the instrument for any purpose for which it is not intended.
- Ensure that the instrument is clean and sterile prior to use.
- If damaged do not reuse; replace.
- Instruments designated for single use only must not be reused and must be properly disposed of.
It is strongly recommended that the patient be informed of the risks associated with surgical procedures and components.
- Carefully read all instructions and be familiar with the surgical technique prior to use.
- Inspect all instruments prior to each use for wear, corrosion, loosening, ageing or fracture. The spacer cutter blade should be periodically replaced to maintain optimal cutting performance.
- If instruments are subjected to excessive loading, are damaged or are handled improperly, they may fracture, corrode, oxidize and show excessive wear or their functionality may be impaired.
- Neutral pH enzymatic and cleaning agents are recommended. Cleaning or disinfecting agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine, iodide, and potassium or sodium hydroxide can accelerate the degradation of these instruments and should not be used.
- Never tighten Universal joints or Rail Clamps without Frame Components or Retractors in the holes. Joints may collapse and be rendered unusable.
- All implants and some instruments are intended for single use only; refer to the product label to determine if the instrument is intended for single use only. Single use devices should not be re-used. Possible risks associated with re-use of single use devices include:
– Mechanical malfunction
– Transmission of infectious agents
Possible adverse effects associated with the use of orthopedic instruments are similar to those associated with any spine surgery, including:
- Nerve damage
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA