BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR CERVICAL SCREW

    MDR report key: 23066 · Received May 20, 1995

    Report

    Report Number
    23066
    Event Type
    Malfunction
    Date Received
    May 20, 1995
    Date of Event
    April 21, 1995
    Report Date
    May 17, 1995
    Manufacturer
    UNKNOWN
    Product Code
    HHO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    REMOVED AND REPLACED CERVICAL PLATE AND 6 SCREWS BECAUSE TWO SCREWS HAD BROKEN. ORIGINAL INSERTION AT ANOTHER FACILITY, NO MFR INFO AVAILABLE. PT STATES IMPLANT DATE MID 1991.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPAR CERVICAL SCREW Implant SCREWS HHO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other