BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND METAGLENE

    MDR report key: 3161777 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18590
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 24, 2013
    Report Date
    June 10, 2013
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    HSD
    PMA / PMN Number
    PK062250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    WHEN TRYING TO ATTACH THE GLENOSPHERE TO THE METAGLENE THE THREAD ON THE IMPLANT STRIPPED OUT. ALTERNATIVE IMPLANT USED. UPDATE (B)(6) 2013, DELAY OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261828 DXTEND METAGLENE METAGLENE HSD 3003895575 DEPUY FRANCE 5204918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other