BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID RESORBABLE CRANIAL CLAMP 18MM

    MDR report key: 2914207 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01508
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GXR
    PMA / PMN Number
    K041611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MFG DOCUMENT WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) SAS FOLLOWS: THE CRANIAL CLAMP BROKE WHILE TRYING TO ACCOMMODATE THE DEVICE WHEN IT IS IN THE WRONG POSITION AFTER PLACEMENT. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RESORBABLE CRANIAL CLAMP 18MM RAPID RESORBABLE CRANIAL CLAMP GXR SYNTHES GMBH 7909732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RAPID RESORBABLE CRANIAL CLAMP