BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC GRAFT ROPE, STERILE

    MDR report key: 1182455 · Received September 12, 2008

    Report

    Report Number
    1220246-2008-00185
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ARTHREX INC.
    Product Code
    HTN
    PMA / PMN Number
    K052776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED FOR EVALUATION, BUT THE EXPLANTED DEVICE WAS NOT RETURNED FOR AN UNKNOWN REASON, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE ORIGINAL IMPLANT LOT NUMBER IS UNKNOWN. DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED WITHOUT THE LOT NUMBER. THIS IS THE ONLY COMPLAINT ON THIS PART NUMBER. FROM THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS NON-COMPLIANCE TO THE POST-OPERATIVE PROTOCOL. IF THE DEVICE IS RETURNED AND/OR ADDITIONAL PATIENT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LOSS OF AC (ACROMIOCLAVICULAR) REDUCTION AT SIX WEEKS POST-OP WHEN HE WAS LIFTING A 300 POUND TIRE. THE SURGEON BELIEVES THIS EVENT WAS DUE TO PATIENT COMPLIANCE ISSUES AND NOT FAILURE OF THE DEVICE. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN 2008. NO FURTHER PATIENT OR OUTCOME INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP REQUESTS TO THE REPORTER. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC GRAFT ROPE, STERILE HTN ARTHREX INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED