BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 207751 · Received January 8, 1998

    Report

    Report Number
    207751
    Event Type
    Injury
    Date Received
    January 8, 1998
    Date of Event
    September 22, 1997
    Report Date
    December 31, 1997
    Manufacturer
    SYNTHES
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED AN INJURY LIFTING A WOODEN PALLET IN DECEMBER OF 1991. PT HAD SURGERY PERFORMED ON 10/11/1996 FOR C5-6, C6-7 ANTERIOR CERVICAL DISKECTOMY WITH INTERBODY FUSION PERFORMED WITH ALLOGRAFT. PT CONTINUED TO HAVE NECK PAIN. X-RAYS PERFORMED IN LATE APRIL 1997 DEMONSTRATED FRACTURE OF THE PLATE SUGGESTING PSEUDOARTHROSIS. AFTER ALLOWING FOR FURTHER TIME TO HEAL THE PT ELECTED TO UNDERGO FURTHER SURGERY. SURGERY PERFORMED ON 09/22/1997 WITH REMOVAL OF FRACTURED PLATE, FOLLOWED BY REVISION OF PSEUDOARTHROSIS AND USE OF AUTOGRAPH FROM THE ILLIAC CREST AND APPLICATION OF NEW INSTRUMENTATION. FACILITY NOTIFIED OF MEDWATCH BY INITIAL REPORTER ON 10/31/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES Implant TITANIUM PLATE KWQ SYNTHES THE FOLLOWING NUMBERS TAKEN *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention