BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR ANTERIOR PLATING SYSTEM TITANIUM SCREWS

    MDR report key: 11036 · Received January 25, 1994

    Report

    Report Number
    MW1000472
    Event Type
    Malfunction
    Date Received
    January 25, 1994
    Report Date
    January 24, 1994
    Manufacturer
    AESCULAP INSTRUMENTS CORP.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SCREWS BREAK, ANYWHERE FROM SEVERAL WEEKS TO SEVERAL MONTHS AFTER IMPLANTATION. OVER THE LAST YEAR, THERE WERE AT LEAST FOUR INCIDENTS. NO PTS SUFFERED ADVERSE EFFECTS OR HAD TO HAVE ADD'L SURGERY. THE RPTR STATED THAT HE HAS USED THIS SYSTEM FOR A LONG TIME AND NEVER HAD A PROBLEM UNTIL THE SCREWS WERE CHANGED FROM STAINLESS STEEL TO TITANIUM. THE RPTR ALSO STATED THAT HE IS AWARE THAT THIS IS NOT AN ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPAR ANTERIOR PLATING SYSTEM TITANIUM SCREWS KWQ AESCULAP INSTRUMENTS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *