BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3173848 · Received June 17, 2013

    Report

    Report Number
    2530088-2013-00945
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    June 17, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THERE WAS NO DAMAGE DETECTED TO THE RETURNED IMPLANTS. UNFORTUNATELY, WE CANNOT EXACTLY PINPOINT THE EXACT REASON FOR THE PROBLEM THAT OCCURRED AFTERWARDS. HOWEVER, WE CAN ASSURE YOU THAT WE HAVE RECEIVED THIS MESSAGE IN OUR MARKET VIGILANCE SYSTEM AND THE ASSOCIATED COMPLAINT STATISTICS ARE KEPT UNDER OBSERVATION. NO PRODUCT ERROR COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOOSE SCREW HEADS. DURING A L4 AND L5 WITH MATRIX SPINAL FUSION L4/5, AFTER HAVING EXPOSED THE SCREWS AND RODS IN SITU, THE DOCTOR ESTABLISHED THAT THE SCREW HEADS IN L4 WERE LOOSE/POLYAXIAL, EVEN THOUGH THE LOCKING CAPS WERE STILL FIRMLY CLOSED AND HAD NOT BEEN MANIPULATED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). REFERENCE COMPLAINTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274365 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6396170

    Patients

    Seq Age Sex Outcome Treatment
    1