BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN ACP CENCELLOUS BONE SCREW

    MDR report key: 367292 · Received December 21, 2001

    Report

    Report Number
    1226348-2001-00207
    Event Type
    Injury
    Date Received
    December 21, 2001
    Date of Event
    November 30, 2001
    Report Date
    December 5, 2001
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP SCREWS OF AN ANTERIOR CERVICAL PLATE CONSTRUCT FRACTURED. SURGEON REMOVED THE TOP PORTIONS OF THE SCREWS. THE REMAINING FRACTURED PORTIONS OF THE SCREWS REMAIN IN THE VERTEBRAL BODY. THIS MEDWATCH REPORT 1226348-2001-207 IS FOR ONE OF THE FRACTURED SCREWS. REFER TO MEDWATDCH REPORT 1226348-2001-208 FOR SECOND FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58213 CODMAN ACP CENCELLOUS BONE SCREW APPLIANCE, FIXATION, SPINAL, INTERVERTEBRAL BODY KWQ CODMAN & SHURTLEFF, INC./MEDOS S.A. NA 36455

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention ACP CANCELLOUS BONE SCREW 46-4196 CODMAN REF#| 0102978C-2, MEDWATCH REPORT 1226348-2001-208.