BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X30MM

    MDR report key: 3971687 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24713
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. THE DHR ANALYSIS OF THE BATCHES PROVIDED SHOWS AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THEIR SPECIFICATION. FOR THESE BATCHES, THERE WAS NO DEVIATION OR NON-CONFORMANCE. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR 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.

    Description of Event or Problem · 1

    REVISION: TOTAL REVERSE SHOULDER, PERFORMED BY (B)(6) ON (B)(6) 2014 AT (B)(6). REASON: INSTABILITY, INCORRECT VERSION, PAIN AND EMOTIONAL STRESS. PRIMARY: DELTA XTEND, PERFORMED BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447814 DXTEND SCREW LOCK D4.5X30MM SHOULDER OTHER IMPLANT KWS DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575 5124376

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention