BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø7 CANN PREASSMBL

    MDR report key: 3171557 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03081
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    December 7, 2010
    Report Date
    January 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENTS SHOWS NO DEVIATION TO THE SPECIFICATION. THE INVESTIGATION OF THE COMPLAINED DEVICE SHOWS THAT CONICAL ELEMENT CAME OFF AND THE WHOLE IMPACT SEPARATED. IN CONNECTION WITH SPIRIT, SIMILAR COMPLAINTS HAVE BEEN REPORTED. IT HAS BEEN RECOGNIZED THAT WHEN PUSHING FORWARD THE HOLDING SLEEVE WHILE INSERTING/ADVANCING THE SCREW INTO THE VERTEBRAE, THE SCREW MAY DISASSEMBLE. THE TECHNIQUE GUIDE WAS ADAPTED IN RESPONSE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A POSTERIOR LUMBAR SPINAL FIXATION PROCEDURE WITH SPIRIT ON (B)(6) 2010, FOUR SCREWS WERE USED. ONE OF THE SCREWS CONICAL ELEMENT CAME OFF. 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
    272432 PEDICSCR PANGEAPOLYAX Ø7 CANN PREASSMBL NKB SYNTHES GMBH 3549546

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR