BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTER

    MDR report key: 3083753 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11134
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE TIP FROM THE UPPER ARM HAS BROKEN OFF FROM THE INSTRUMENT. THE RESULTS OF THIS ANALYSIS WERE THAT THE FAILURE APPEARS TO BE DUE TO AN OVERLOAD OF THE MATERIAL. THIS IS CONSISTENT WITH PDS INITIAL OBSERVATIONS. THE REPORT ALSO MENTIONS INTERGRANULAR ATTACK, BUT THE RESULTS WERE INCONCLUSIVE AS TO WHETHER THIS OCCURRED DUE TO THE FRACTURE OR BEFORE THE FRACTURE. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN STANDPOINT. THIS COMPLAINT WAS DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRODISC-C PROCEDURE AT LEVELS C4-C5 AND C5-C6, THE TIP OF THE IMPLANT HOLDER BROKE OFF. THIS OCCURRED DURING THE IMPLANTATION OF THE DISC AT C4-C5. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE SURGEON USED THE REMOVAL HANDLE TO FINISH INSERTING THE DISC AT THE FIRST LEVEL. THE CONSULTANT PROVIDED A BACK-UP INSERTER SO THE SURGEON COULD COMPLETE INSERTING THE DISC AT THE ADJACENT LEVEL, AND FINISH THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT, AND NO SIGNIFICANT TIME ADDED TO THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185418 IMPLANT INSERTER LXH SYNTHES GMBH T921171

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR