BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X36MM

    MDR report key: 6048112 · Received October 21, 2016

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    Report

    Report Number
    1818910-2016-29955
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    HSD
    PMA / PMN Number
    K120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A DHR REVIEW FOUND NO NON-CONFORMANCES. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    WHILE INSERTING THE LOCKING SCREW BECAME BOUND IN THE BONE AND CONSEQUENTLY THE TINES OF THE HEAD OF THE SCREW STRIPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698405 DXTEND SCREW LOCK D4.5X36MM SHOULDER OTHER IMPLANT HSD DEPUY FRANCE SAS 3003895575 5272595

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention