BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE DOWEL - IRRADIATED 1.4CM

    MDR report key: 5140 · Received May 17, 1993

    Report

    Report Number
    5140
    Event Type
    Malfunction
    Date Received
    May 17, 1993
    Date of Event
    April 15, 1993
    Report Date
    May 4, 1993
    Manufacturer
    MICHIGAN TISSUE BANK
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ANTERIOR CERVICAL FUSION ON 4/15/93. TWO BONE DOWELS WERE INSERTED AS IMPLANTS AND CRUMBLED. (ONE FROM DAYTON REGIONAL TISSUE BANK AND ONE FROM MICHIGAN TISSUE BANK). THIS NECESSITATED A "REDO" OF THE PROCEDURE TO REMOVE DOWELS AND REPLACE BONE WITH ILIAC CREST GRAFTS FROM PATIENT'S OWN HIP AND FUSE WITH SYNTHES CERVICAL PLATEDEVICE LABELED FOR SINGLE USE. 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. 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. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE DOWEL - IRRADIATED 1.4CM Implant LMO MICHIGAN TISSUE BANK 162-92-38

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other