Mergence® -S Spinal Instrumentation System

Description

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.

Indications

The instrument(s) is indicated for general surgical use in orthopedic procedures.

Contraindications

This does not identify specific procedural contraindications because the instrument(s) is intended for general surgical use. General use contraindications include:

• Infection
• Fever
• Local inflammation

Warnings:

• 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.

Precautions

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:

• Infection
• Nerve damage
• Bleeding
• Scarring
• Pain

USA: 720-894-9016

To submit a complaint, please email SpineComplaints@highridgemedical.com

10225 Westmoor Dr. Westminster, CO 80021 USA

To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 720-894-9016.

Zimmer Biomet Spine, Inc.

10225 Westmoor Dr.

Westminster, CO 80021 USA