BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3193276 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01718
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 28, 2012
    Manufacturer
    SYNTHES MONUMENT
    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE EXECUTED INSPECTION OF THE BRACKET CASING SHOWED THAT A PIECE OF THE THREAD BROKE OFF ON THE TIP OF THE THREAD AND REMAINED IN THE PEDICLE SCREW HEAD. UNFORTUNATELY, IT IS NOT POSSIBLE FOR US TO UNDERSTAND HOW THIS DAMAGE OCCURRED. NO PRODUCT ERRORS COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD WAS BROKEN WHILE TURNING THE SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294132 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6583190

    Patients

    Seq Age Sex Outcome Treatment
    1