BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 185148 · Received September 2, 1998

    Report

    Report Number
    185148
    Event Type
    Injury
    Date Received
    September 2, 1998
    Date of Event
    August 20, 1998
    Report Date
    August 21, 1998
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INJURED 10/21/1991. HAD AN ANTERIOR CERVICAL DISC FUSION IN 1992 AND 1996. SURGERY ON 10/03/1997 WAS ANTERIOR CERVICAL DISC FUSION C4-5 USING RIGHT ILIAC CREST BONE GRAFT AND SYNTHES CERVICAL LOCKING SET PLATE AND SCREWS. PATIENT DISCHARGE INSTRUCTIONS WERE TO WEAR NECK COLLAR 4 TO 12 WEEKS POSTOP. NOT TO DRIVE FOR 3 TO 4 WEEKS, NO VACUUMING, MOWING FOR 3 MONTHS AND NO HEAVY LIFTING. BECAUSE OF FAILURE TO IMPROVE WITH CONSERVATIVE THERAPY, PERSISTENT PAIN DISABILITY AND INCAPACITY. PATIENT WAS ADMITTED FOR SURGERY. REMOVAL OF DEVICE REVEALED RIGHT INFERIOR C5 SCREW HEAD WAS FRACTURED AS WELL AS LEFT SCREW. BONE GRAFT WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES Implant CERVICAL SCREWS HWC SYNTHES 488.814 4.35 MM X4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SYNTHES CERVICAL PLATE