BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZICKLE IM ROD LEFT

    MDR report key: 6073 · Received July 27, 1993

    Report

    Report Number
    33462-1993-01084
    Event Type
    Injury
    Date Received
    July 27, 1993
    Date of Event
    July 9, 1993
    Report Date
    July 12, 1993
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NON-UNION OF SUB TROCKANTERIC FX W/FATIGUE FRACTURE O ZICKEL IM ROD. PATIENT WALKED ON NON-UNION UNTIL ROD BROKE. ROD WAS REMOVED AND REPLACED WITH HEAVIER I.M. ROD OF TITANIUMDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZICKLE IM ROD LEFT Implant IM ROD HSB HOWMEDICA, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention