BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPEDSCHANZSCR Ø6.2 L190/45 TAN DBLUE

    MDR report key: 3010178 · Received March 19, 2013

    Report

    Report Number
    8030965-2013-00961
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: KWP, KWQ, MNH. PMA 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, TWO SCHANZ SCREW WOULD NOT ADVANCE THROUGH THE FRACTURE CLAMP. REPORTEDLY THE SCHANZ SCREWS COULD NOT BE USED DURING THE OPERATION. ANOTHER SCREW WAS AVAILABLE FOR USE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT AND THE SURGERY WAS NOT DELAYED DUE TO THIS OCCURRENCE. THE EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT. THIS REPORT IS FOR TWO SCHANZ SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114891 TRANSPEDSCHANZSCR Ø6.2 L190/45 TAN DBLUE MNI SYNTHES GMBH 8123409

    Patients

    Seq Age Sex Outcome Treatment
    1