BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C 7MM INSERTER

    MDR report key: 3841672 · Received May 30, 2014

    Report

    Report Number
    0009617544-2014-00248
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    ODP
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: FUNCTIONAL DEVICE INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE PROBABLE CAUSE IS MULTIFACTORIAL IN NATURE. CONCLUSION: THE ANCHOR C 7MM INSERTER WAS CONFIRMED TO HAVE A BENT SHAFT UPON VISUAL INSPECTION. THIS ISSUE WAS FOUND DURING AN INSPECTION. THERE WAS NOT PATIENT INVOLVEMENT OR HARM REPORTED. NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON INSPECTION OF LOANER KIT FOUND THAT THE 7MM WAS INSERTER BENT & CROSS THREADED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON INSPECTION OF LOANER KIT FOUND THAT THE 7MM WAS INSERTER BENT & CROSS THREADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318514 ANCHOR C 7MM INSERTER INSTRUMENT-INSERTER ODP STRYKER SPINE-FRANCE 111584

    Patients

    Seq Age Sex Outcome Treatment
    1