BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIC PEEK SIZE 9 MM - 4DEG

    MDR report key: 3678567 · Received March 14, 2014

    Report

    Report Number
    0009617544-2014-00108
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 19, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE PEEK SIZE 9 MM - 4DEG CAGE BREAKAGE DURING INSERTION IS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED PRODUCT. IT WAS REPORTED THAT ALL PARTICLES WERE REMOVED FROM THE PATIENT AND NO HARM WAS REPORTED ASSOCIATED WITH THIS EVENT. NO ANOMALIES WERE IDENTIFIED IN THE MANUFACTURING RECORDS THAT MAY HAVE LED TO THE REPORTED EVENT. THE SURGICAL TECHNIQUE STATES THAT THE CAGE MUST BE INSERTED GENTLY AND PROGRESSIVELY INTO THE DISC SPACE AND TO ENSURE THAT THE INTERVERTEBRAL SPACE IS ACCESSIBLE, THE CONTRALATERAL DISTRACTOR IS LEFT IN PLACE DURING THE CAGE PLACEMENT. PREVIOUS COMPLAINTS HAVE STATED THAT EXCESSIVE IMPACTION FORCE, OVERSIZED IMPLANT, AND INADEQUATE DISCECTOMY/DISTRACTION ARE COMMON CAUSES OF IMPLANT BREAKAGE. DEFORMATION TO THE CAGE INDICATES THAT THE FRACTURE RESULTED FROM A CANTILEVER LOAD. CONCLUSION: THE MOST LIKELY CAUSE OF THE BREAKAGE WAS APPLICATION OF CANTILEVER FORCE DURING INSERTION. HOWEVER, THE EXACT CAUSE CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL IN NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON TRIED TO INSERT OIC PEEK USING INSERTER, OIC PEEK BROKE. THEREFORE, THE SURGEON REMOVED BROKEN OIC PEEK. THE SURGEON CHANGED OIC PEEK TO ANOTHER IMPLANT AND THE OPERATION WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON TRIED TO INSERT OIC PEEK USING INSERTER, OIC PEEK BROKE. THEREFORE, THE SURGEON REMOVED BROKEN OIC PEEK. THE SURGEON CHANGED OIC PEEK TO ANOTHER IMPLANT AND THE OPERATION WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153811 OIC PEEK SIZE 9 MM - 4DEG IMPLANT- SPACER MAX STRYKER SPINE-FRANCE 58680

    Patients

    Seq Age Sex Outcome Treatment
    1