BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.D. SCREWS AND RODS

    MDR report key: 9073 · Received October 26, 1994

    Report

    Report Number
    2530027-1994-09002
    Event Type
    Injury
    Date Received
    October 26, 1994
    Date of Event
    January 21, 1994
    Report Date
    March 1, 1994
    Manufacturer
    SOFAMOR DANEK
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM THE PARENT COMPANY IN THE FORM OF A LEGAL INDICTMENT, DURING EVENING OF JANUARY 21, 1994. AS THE CITED A MANUFACTURER OF THE DEVICES, THE INFORMATION WAS RE-TRANSSMITTED TO US, AND RECEIVED HERE SATURDAY 1/22/94.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.D. SCREWS AND RODS PEDICLE SCREW SYSTEM MCV SOFAMOR DANEK UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention