BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM

    MDR report key: 3030903 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10642
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    September 7, 2011
    Report Date
    September 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PLACEHOLDER.

    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L4-L5, THE TIP OF THE SPINDLE BROKE OFF INSIDE THE TRIAL SPACER. THE TRIAL WAS REMOVED FROM THE PATIENT. THE SURGEON THEN PLACED THE PROPER IMPLANT AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135209 SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM NKB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1