BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASEPLATE

    MDR report key: 4169813 · Received October 14, 2014

    Report

    Report Number
    0002249697-2014-03885
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K130895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). 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 PREFORMED AS NO PRODUCTS WERE PROVIDED FOR INSPECTION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PREFORMED 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.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WHEN INSERTING THE BASEPLATE WITH THE 6.5 CENTER SCREW, THE SURGEON WAS NOT ABLE TO COMPRESS THE BASEPLATE TO THE GLENOID. WE TRIED MULTIPLE TIMES TO GET THE BASEPLATE TO COMPRESS WITH NO SUCCESS. THE SURGEON CHOSE TO USE A COMPETITOR'S SYSTEM AND COMPLETED THE CASE WITHOUT ANY DELAY TO THE SURGERY OR HARM TO PATIENT.

    Description of Event or Problem · 1

    WHEN INSERTING THE BASEPLATE WITH THE 6.5 CENTER SCREW, THE SURGEON WAS NOT ABLE TO COMPRESS THE BASEPLATE TO THE GLENOID. WE TRIED MULTIPLE TIMES TO GET THE BASEPLATE TO COMPRESS WITH NO SUCCESS. THE SURGEON CHOSE TO USE A COMPETITOR'S SYSTEM AND COMPLETED THE CASE WITHOUT ANY DELAY TO THE SURGERY OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650840 BASEPLATE IMPLANT KWS STRYKER ORTHOPAEDICS-MAHWAH MNK01K

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other