BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND SCREW LOCK D4.5X30MM

    MDR report key: 3893530 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21911
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    EXAMINATION OF THE RETURN PRODUCTS BY A DEPUY FRANCE SUPPLIER CONFIRMED THE COMPLAINT. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE; THE PRODUCTS WERE DETERIORATED DURING THE ASSEMBLY. 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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

    IT WAS NOT POSSIBLE TO SCREW THE GLENOSPHERE INTO THE METAGLENE. ANOTHER PRODUCT WAS AVAILABLE. NO SURGERY PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371166 DXTEND SCREW LOCK D4.5X30MM MISC EXTREMITY IMPLANT KWS DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955 5226628

    Patients

    Seq Age Sex Outcome Treatment
    1