BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L INSERTER F/SIZE L

    MDR report key: 3171605 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03088
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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). A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. THE INVESTIGATION OF THE INSTRUMENT HAS SHOWN THAT THE TWO PINS ARE SEVERED. EVIDENCE INDICATES THAT EXCESSIVE MECHANICAL STRESS CAUSED THESE PINS TO BREAK. THIS DESIGN WAS REVISED IN 2007, THE PRESENT ARTICLE STILL REFLECTS THE PREVIOUS DESIGN FROM 2006.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIPS OF THE INSTRUMENT BROKE OFF ON AN UNKNOWN DATE. IT IS UNKNOWN WHERE THIS OCCURRED. 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
    272612 PRODISC-L INSERTER F/SIZE L LXH SYNTHES GMBH A7PA30

    Patients

    Seq Age Sex Outcome Treatment
    1