BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-C VERTEBR-BODY RETAINER

    MDR report key: 3173792 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03381
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 10, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE PREVIOUS DESIGN. THE EVALUATION REVEALED THAT ONE OF THE PINS THAT HOLDS THE LOCKING LEVER IN POSITION INDEED BROKE OFF. WE SUPPOSE THAT THE BREAKAGE OCCURRED DURING A MECHANICAL OVERLOADING SITUATION. UNFORTUNATELY WE ARE NOT ABLE TO REPAIR THIS INSTRUMENT AS WE DO NOT STOCK SPARE PARTS FOR THIS ITEM. PLEASE NOTE THAT DUE TO SIMILAR REPORTED COMPLAINTS FROM THE MARKET, A DESIGN IMPROVEMENT OF THE PIN HAS BEEN INTRODUCED. THIS INSTRUMENT WAS MANUFACTURED ACCORDING TO THE PREVIOUS DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER DEVICE IS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273385 PRODISC-C VERTEBR-BODY RETAINER LXH SYNTHES GMBH A7NA40

    Patients

    Seq Age Sex Outcome Treatment
    1