BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE

    MDR report key: 4233356 · Received November 6, 2014

    Report

    Report Number
    0002249697-2014-04207
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K130895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY SEATING A REVERSE SHOULDER BASEPLATE AND CENTER SCREW WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCTS WERE PROVIDED FOR INSPECTION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICE WAS PROVIDED FOR INSPECTION AND NO PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

    CENTER SCREW ON REVERSE BASEPLATE WOULD NOT SEAT. DRILLED UP TO 4.2 MM TO GET SCREW TO SEAT.

    Description of Event or Problem · 1

    CENTER SCREW ON REVERSE BASEPLATE WOULD NOT SEAT. DRILLED UP TO 4.2 MM TO GET SCREW TO SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713359 BASEPLATE IMPLANT KWS STRYKER ORTHOPAEDICS-MAHWAH MNKV30

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other