BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM

    MDR report key: 3073267 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-10972
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    June 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. (B)(4). 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. ACCORDING TO THE PRODUCT DEVELOPMENT EVENT EVALUATION AND A REVIEW OF SYNTHES DEVICE HISTORY RECORDS, 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.

    Description of Event or Problem · 1

    CONSULTANT REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF BROKEN NON-SYNTHES HARDWARE. PATIENT WAS REVISED TO ALIF (SYNFIX) AT LEVELS L5-S1, AND PLF (USS FIXATION) AT LEVELS T10-S1. IN IMPLANTING THE SYNFIX, THE FOLLOWING OCCURRED: THE SYNFIX TRIAL SPACER HANDLE TIP BROKE OFF IN THE SYNFIX TRIAL IMPLANT. WHILE TRYING TO REMOVE THE TRIAL IMPLANT, THE TIP OF THE AWL BENT. THE TRIAL IMPLANT WAS REMOVED AND SURGEON RETRIEVED ALL FRAGMENTS OF THE HANDLE TIP. SURGEON THEN PLACED THE SYNFIX IMPLANT AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS 1 OF 2 REPORTS FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175234 SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM HWT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR