BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR ARTHRODESIS NAIL 0 DEGREE COLLAR ASSEMBLY WITH LOCKING BOLTS

    MDR report key: 6113751 · Received November 18, 2016

    Report

    Report Number
    0001825034-2016-04743
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK042409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY. (B)(4). MEDICAL PRODUCT - BIOMET OSS INTLK BOWED IM STEM, CATALOG#: 150372 LOT#: 068430. THERAPY DATE - (B)(6) 2016.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT ORTHOPEDIC SALVAGE SYSTEM PROCEDURE AND APPROXIMATELY ONE YEAR POST-IMPLANTATION WAS REVISED DUE TO THE ARTHRODESIS NAIL FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763487 MODULAR ARTHRODESIS NAIL 0 DEGREE COLLAR ASSEMBLY WITH LOCKING BOLTS ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A 360610

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R SEE NARRATIVE IN H10