BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 176911 · Received July 9, 1998

    Report

    Report Number
    176911
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    June 30, 1998
    Report Date
    July 6, 1998
    Manufacturer
    SYNTHES
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD MOTOR VEHICLE ACCIDENT ON 9/9/1995, SUSTAINING CERVICAL4-CERVICAL5 DISK HERNIATION. ON 1/25/1996, SHE HAD CERVICAL4-CERVICAL5 ANTERIOR CERVICAL DISK FUSION. HOME WITH NECK COLLAR TO BE WORN 4-12 WEEKS POST SURGERY. NO DRIVING 3 - 4 WEEKS AND NO LIFTING OVER 20 POUNDS. DID WELL, BUT GRADUALLY STARTED HAVING RECURRENT SYMPTOMS, WHICH GOT WORSE. XRAYS AND COMPUTERIZED TOMOGRAPHY-SCAN REVEALED FRACTURED CERVICAL PLATE WITH A CERVICAL4-CERVICAL5 PSEUDORARTHROSIS WITH SLIGHT CERVICAL4-CERVICAL5 RETROLISTHESIS. BECAUSE OF SEVERE, INTRACTABLE PAIN, FAILURE OF CONSERVATIVE TREATMENT, PT WAS READMITTED FOR PARTIAL CERVICAL4-CERVICAL5 CORPECTOMIES WITH SPINAL NERVE ROOT DECOMPRESSION, ANTERIOR CERVICAL FUSION, CERVICAL4-CERVICAL5 TRICORTICAL ILIAC CREST AUTOGRAFT AND #20 TITANIUM SYNTHES PLATE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES Implant #18 TITANIUM SYNTHES PLATE WITH SCEWS KWQ SYNTHES PLATE *
    2 SYNTHES Implant #18 TITANIUM SYNTHES PLATE WITH SCREWS KWQ SYNTHES SCREWS *
    3 SYNTHES Implant #18 TITANIUM SYNTHES PLATE WITH SCREWS KWQ SYNTHES SCREWS *
    4 SYNTHES Implant #18 TITANIUM SYNTHES PLATE WITH SCREWS KWQ SYNTHES SCREWS *
    5 SYNTHES Implant #18 TITANIUM SYNTHES PLATE WITH SCREWS KWQ SYNTHES SCREWS *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention