BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL SPACER-PR 10MMX24MM 7MM HEIGHT

    MDR report key: 3070692 · Received April 22, 2013

    Report

    Report Number
    3003506883-2013-10118
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    September 27, 2011
    Report Date
    September 27, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    MQP
    PMA / PMN Number
    K011037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED IN FOUR LARGE PIECES AND WITH ONE SMALL FRAGMENT. THE TWO LARGEST PIECES CONTAIN THE MARKER PINS IN THE CORRECT LOCATIONS. THERE IS POST-MANUFACTURING DAMAGE CONSISTING OF A GOUGE AND DISPLACED MATERIAL IN THE AREA OF THE PART NUMBER LASER ETCH. SOME FEATURES THAT WERE INSPECTED WERE DAMAGED POST-MANUFACTURING AND MEASUREMENTS WERE UNOBTAINABLE. ALL FEATURES THAT WERE INTACT MEASURED WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED, IT IS UNCLEAR WHAT COULD HAVE RESULTED IN THE IMPLANT BREAKAGE. EXCESSIVE LOADING WHILE IMPLANTATION, INCORRECT SURGICAL TECHNIQUE, INCORRECT IMPLANT SIZE, COULD RESULT IN BREAKAGE OF AN IMPLANT DURING IMPLANTATION. THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    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.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4). PER FOLLOW UP INFORMATION, THE PATIENT UNDERWENT REHABILITATION AND IMPROVED POST SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE FROM L2 TO T10, WITH A PEEK SPACER AT ONE LEVEL, ABOVE EXISTING HARDWARE AT L2-S1. THE SURGEON IMPACTED THE SPACER AND IT BROKE IN SITU. ALL PIECES WERE REMOVED AND A NEW SPACER WAS USED. THE SECOND SPACER WAS PLACED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. PER ADDITIONAL INFORMATION, IT WAS REPORTED VIA MEDWATCH REPORT # (B)(4), THAT THE INITIAL PROCEDURE WAS REMOVAL OF LUMBAR POSTERIOR SEGMENTAL INSTRUMENTATION, BILATERAL L1-L2 GILL LAMINECTOMY, L1-L2 POSTERIOR LUMBAR INTERBODY FUSION, AND L1-L2 PLACEMENT OF INTERBODY FUSION CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171645 VERTEBRAL SPACER-PR 10MMX24MM 7MM HEIGHT MQP SYNTHES ELMIRA 5000054

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR