BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WURZBURG MANDIBULAR PLATE

    MDR report key: 115513 · Received August 22, 1997

    Report

    Report Number
    8010177-1997-00044
    Event Type
    Malfunction
    Date Received
    August 22, 1997
    Report Date
    August 21, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    JAZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: EVALAUTION RESULTS AS RECEIVED FROM HOWMEDICA LEIBINGER GMBH INDICATES THAT THE PROBABILITY OF THE IMPLANT MATERIAL OF BEING THE SOLE SOURCE OF INFECTION IS RARE. REFERENCE LITERATURE INDICATES TITANIUM IMPLANTS HAVE POSSIBILITIES OF INFECTION BUT ONLY IN VERY FEW DEFINED OCCURRENCES.

    Description of Event or Problem · 1

    A WURZBURG MANDIBULAR PLATE AND RELATED SCREWS WERE REMOVED FROM A PATIENT BECAUSE OF AN INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WURZBURG MANDIBULAR PLATE Implant IMPLANT JAZ STRYKER INSTRUMENTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other WURZBURG MANDIBULAR BONE SCREWS