BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDLH

    MDR report key: 279146 · Received May 17, 2000

    Report

    Report Number
    279146
    Event Type
    Injury
    Date Received
    May 17, 2000
    Date of Event
    May 10, 2000
    Report Date
    May 16, 2000
    Manufacturer
    DANEK MED. INC.
    Product Code
    MNH
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PREVIOUS SURGERY WITH MULTIPLE HARDWARE PIECES IMPLANTED. BOLT FRACTURED. ALL HARDWARE REMOVED AND REPLACED. PT OPERATED ON WITH DIAGNOSIS OF "FAILED BACK SYNDROME." SURGEON UNAWARE OF FRACTURE IN BOLT UNTIL FUSION OF L4-5 LEVEL. (DIAGNOSIS OF SPONDYLOLISTHESIS L3-4, L5-S1 STENOSIS.) HARDWARE MAILED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDLH ORTHOPEDIC HARDWARE IMPLANTS 7.0X50MM BOLT X 2 MNH DANEK MED. INC. * *
    2 GDLH ORTHOPEDIC HARDWARE IMPLANTS 7.5X45MM BOLT X 2 MNH DANEK MED. INC. * *
    3 GDLH ORTHOPEDIC HARDWARE IMPLANTS ROD/BOLT CONNECTOR X 4 MNH DANEK MED. INC. * *
    4 GDLH ORTHOPEDIC HARDWARE IMPLANTS SPACERS X 4 MNH DANEK MED. INC. * *
    5 GDLH ORTHOPEDIC HARDWARE IMPLANTS GUIDEWIRES X 4 MNH DANEK MED. INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention