BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTEX SCREW S.T. Ø4.5X44MM

    MDR report key: 8784644 · Received July 12, 2019

    Report

    Report Number
    0008031020-2019-00828
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 21, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    UDI-DI
    07613327081138
    PMA / PMN Number
    K050512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. BASED ON THE GIVEN INFORMATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE PATIENT RELATED. THE FAILURE WAS CAUSED DUE TO THE MENTIONED POOR BONE QUALITY WHICH RESULTED IN THE FRACTURE OF THE ACETABULUM DURING THE THA PROCEDURE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES, DUE TO THE FACT AS DURING THA PROCEDURE, SURGEON WAS IMPACTING THE CUP AND FRACTURED THE ACETABULUM. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    PATIENT IN (B)(6)2018 HAD A HIP FRACTURE AND HAD AN OMEGA PLATE/LAG SCREW AS WELL 7.2 CANNULATED SCREW. HARDWARE WAS REMOVED PRIOR TO STARTING THA PROCEDURE. AS REPORTED IN PI # 2121579: "DURING THA PROCEDURE, SURGEON WAS IMPACTING THE CUP AND FRACTURED THE ACETABULUM. SURGEON POINTED OUT THAT THE BONE QUALITY WAS POOR. REGISTRATION WAS 0.2. PATIENT IN (B)(6)2018 HAD A HIP FRACTURE AND HAD AN OMEGA PLATE/LAG SCREW AS WELL 7.2 CANNULATED SCREW. HARDWARE WAS REMOVED PRIOR TO STARTING THE HIP PROCEDURE. WHILE FIXING THE ACETABULUM HE HAD A HARD TIME GET THE SCREWS FIXATED. CASE WAS COMPLETED ROBOTICALLY. SURGICAL DELAY - 1 HR WHILE PLACING PLATE AND SCREW".

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    PATIENT IN (B)(6) 2018 HAD A HIP FRACTURE AND HAD AN OMEGA PLATE/LAG SCREW AS WELL 7.2 CANNULATED SCREW. HARDWARE WAS REMOVED PRIOR TO STARTING THA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577405 CORTEX SCREW S.T. Ø4.5X44MM SCREW, FIXATION, BONE HWC STRYKER GMBH UNKNOWN 07613327081138

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention