BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSS PLATE MTP, LEFT ANCHORAGE

    MDR report key: 3891188 · Received June 24, 2014

    Report

    Report Number
    0008031020-2014-00100
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    July 1, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED BREAKAGE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY OVERLOADING. THE PATIENT WAS REPORTED TO BE OBESE; BMI: 31.4 BMI CATEGORY: OBESE CLASS ONE (MODERATELY OBESE). THE PLATE WAS EXPLANTED 3 MONTHS AFTER THE INITIAL SURGERY AND NEEDED TO BE REPLACED, THERE WAS A DELAYED UNION WHICH COULD HAVE CONTRIBUTED TO THE BREAKAGE IN CONJUNCTION WITH THE PATIENT WEIGHT. PLEASE NOTE THAT THE CURRENT IFU READS: PRECAUTIONS FOR USE: IT IS NECESSARY TO INFORM THE PATIENT OF THE PRECAUTIONS TO BE TAKEN TO ENSURE THE SUCCESS OF THE IMPLANTATION. [...] FACTORS CAPABLE OF COMPROMISING IMPLANTATION SUCCESS. BONE PATHOLOGY, OSTEOPOROSIS, BONE TUMORS, SYSTEMIC OR METABOLIC PROBLEMS AND INFECTIOUS DISEASES. EXCESS WEIGHT, INTENSE PROFESSIONAL OR SPORTING PHYSICAL ACTIVITY THAT EXPOSES THE IMPLANT TO EXCESSIVE OR REPEATED LOADS. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVED A BROKEN ANCHORAGE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369759 CROSS PLATE MTP, LEFT ANCHORAGE PLATE, FIXATION, BONE HRS STRYKER GMBH R13872

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention