BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE Ø3.5 CANN RADIOLUC L253 F/

    MDR report key: 3171626 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02953
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    December 1, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). THE INVESTIGATION USING THE MATERIAL AND MANUFACTURING DOCUMENTS REVEALED THAT THE PEDICLE AWL WAS MANUFACTURED ACCORDING TO THE VALID SPECIFICATIONS AND MEETS THE AO/ASIF SPECIFICATIONS AND INTERNATIONAL STANDARDS. THIS IS THE FIRST COMPLAINT RECEIVED FOR THIS ARTICLE. THERE IS EVIDENCE THAT THE AWL WAS HAMMERED IN APPROXIMATELY 15 MM AND THEN BENT BY 180 DEGREES (IN THE SHAFT) WHERE EXCESSIVE HANDLING ULTIMATELY CAUSED THIS DAMAGE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2011, THE PEDICLE PROBE BENT. 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
    272854 PEDICLE PROBE Ø3.5 CANN RADIOLUC L253 F/ HXB SYNTHES GMBH 7595680

    Patients

    Seq Age Sex Outcome Treatment
    1