BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

    MDR report key: 2970784 · Received February 20, 2013

    Report

    Report Number
    3003506883-2013-10035
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    MQP
    PMA / PMN Number
    K011037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    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 (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING . DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PEEK SPACER WAS RECEIVED, FULLY INTACT. VISUAL INSPECTION NOTED POST PRODUCTION/ACCEPTANCE DAMAGE TO THE INSTRUMENT SLOT WITH MATERIAL DISPLACED SLIGHTLY TO THE CROSS SLOT. ADDITIONALLY NOTED, POST PRODUCTION/ACCEPTANCE VERTICAL INDENTIONS ON THE OUTSIDE OF THE PART IN THE AREA OF THE "11" LASER ETCH. A REVIEW OF DEVICE HISTORY RECORD DID NOT REVEAL ANY CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). CORRECT 501K NUMBER IS K011037.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) PROCEDURE AT L4-L5, THE SPACER BROKE AS THE SURGEON INSERTED THE SPACER WITH THE INSTRUMENT. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74855 VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT MQP SYNTHES ELMIRA 6797631

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR