BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø5 PREASSM

    MDR report key: 3192506 · Received June 27, 2013

    Report

    Report Number
    2530088-2013-00926
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    November 23, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE SCREW HEAD LOST POLYAXIALITY. THE DESCRIBED MALFUNCTIONS SUBSTANTIATE THAT THE POLYAXIAL SCREW HEAD TURNS ONLY AFTER APPLYING EFFORTS. HOWEVER, THE EXACT CAUSE OF DAMAGE CANNOT BE DEFINED. AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HEAD LOST POLYAXIALITY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292937 PEDICSCR MATRIX 5.5 POLYAXIAL Ø5 PREASSM NKB SYNTHES BRANDYWINE 6363021

    Patients

    Seq Age Sex Outcome Treatment
    1