BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED PELVIC OSTEOTOME 20MM WIDTH

    MDR report key: 2995394 · Received March 8, 2013

    Report

    Report Number
    8030965-2013-00752
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    EMM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING PERI OSTEOTOMY OPERATION ON (B)(6) 2013, THE CHISEL BROKE OFF AT THE HANDLE AND DISCONNECTED FROM THE REST OF THE CHISEL. THE CHISEL WAS STUCK IN THE BONE AND THEY HAD TO USE ANOTHER DEVICE TO GET IT OUT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. SURGERY PROLONGED APPROXIMATELY 10 TO 15 MINUTES. SALES CONSULTANT WAS NOT IN THE OR AND WAS TOLD BY THE COORDINATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99070 CURVED PELVIC OSTEOTOME 20MM WIDTH OSTEOTOME EMM SYNTHES GMBH T934535

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention