BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX(TM)-LR TRIAL IMPL 12DEGDEPTH 26MM/W 32MM/H 13.5MM

    MDR report key: 3041706 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10763
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    September 21, 2011
    Report Date
    September 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE TIP OF THE TRIAL SPACER HANDLE IS BROKEN OFF IN THE THREADED HOLE OF THE SPACER. THERE ARE NUMEROUS SCUFFS AND SCRAPES ALL OVER THE PART. THERE IS A RED LINE MARKED HORIZONTALLY ACROSS THE SURFACE WITH THE THREADED HOLE AND RED HUE ON THE FRONT FACES OF THE PART. THE ISSUE WITH THE TIP OF THE TRIAL SPACER HANDLE BREAKING INTO THE TRIAL IMPLANT HAS BEEN INVESTIGATED ON SEVERAL PRIOR COMPLAINTS. IT HAS BEEN DETERMINED THAT THE ISSUE IS UNRELATED TO THE TRIAL IMPLANTS, 03.802.000 - 03.802.019 AND THEREFORE THIS COMPLAINT FOR THE TRIAL IMPLANT IS INVALID. DESIGN OF THE TRIAL SPACER IS ACCEPTABLE AND THE COMPLAINT CONDITION IS UNRELATED TO THE SPACER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ALIF PROCEDURE AT L4-L5, THE TIP OF THE HANDLE BROKE OFF INSIDE THE TRIAL SPACER. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THE SURGEON PROCEEDED TO PLACE THE IMPLANT AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144111 SYNFIX(TM)-LR TRIAL IMPL 12DEGDEPTH 26MM/W 32MM/H 13.5MM MQP SYNTHES GMBH 2409447

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR