BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L55 T

    MDR report key: 3171579 · Received June 15, 2013

    Report

    Report Number
    2530088-2013-00909
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(6). MANUFACTURING DOCUMENTS WERE CHECKED AND IT WAS FOUND THAT ALL THE SPECIFICATIONS WERE MET. AN ANALYSIS OF THE SCREW SHOWS THAT THE FAILURE OF THE IMPLANT IS DUE TO AN INCORRECT HANDLING WHILE TURNING THE SCREW, THE GOLDEN COLLET TURNED IN THE SCREW HEAD. THIS MAY HAVE CAUSED THE HEAD TO JUMP OFF AND / OR THE ROD WAS NOT ABLE TO BE INSERTED PROPERLY. EVIDENCE FINDS THAT THERE WAS NO PRODUCT FAILURE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY ON AN UNKNOWN DATE, THE SCREW HEAD DETACHED WHILE TIGHTENING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272598 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L55 T NKB SYNTHES BRANDYWINE 6655036

    Patients

    Seq Age Sex Outcome Treatment
    1