BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY DISTRACTION PEG

    MDR report key: 3072422 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10741
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 5, 2012
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED A BROKEN AND MISSING TIP. THE 4.0 TO 5.0 MM SHAFT IS BADLY MARKED, SCORED, AND SCRATCHED, ESPECIALLY NEAR THE TIP. THE LASER ETCH EXHIBITS MINOR UNKNOWN DISCOLORATION. THE SHAFT HAS A BROWNISH-RED BAND NEAR THE KNURLED DIAMETER. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2012. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED. THE DESIGN IS APPROPRIATE FOR ITS INTENDED USE, TO ASSIST IN DISTRACTION OF THE RIB SLEEVES. BASED ON THE EVENT DESCRIPTION, THE INSTRUMENT WAS USED IN A MANNER IT WAS NOT INTENDED FOR (AS A TOOL TO REMOVE A HOOK), AND BROKE DURING THAT USE. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON COMPLETION OF VEPTR TREATMENT, SURGEON DID A PLANNED PROCEDURE TO REMOVE THE VEPTR HARDWARE AND REVISE THE PATIENT TO TLIF T2-L2 FUSION. WHILE REMOVING THE HARDWARE, THE SURGEON USED A VEPTR TEMPORARY DISTRACTION PEG TO TRY TO PULL OUT ONE OF THE HOOKS. THE TIP OF THE PEG BROKE OFF, AND WAS RETRIEVED IMMEDIATELY. HE THEN USED A SECOND TEMPORARY DISTRACTION PEG, AND THE TIP BENT TRYING TO REMOVE HOOK. HE USED A THIRD PEG, WHICH ALSO BENT AT THE TIP, BUT THE SURGEON DID SUCCESSFULLY REMOVE THE HOOK. PATIENT WAS REVISED TO TLIF T2-L2 FUSION, AND SURGEON COMPLETED THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174263 TEMPORARY DISTRACTION PEG LXH SYNTHES MONUMENT 69774 / 5749674

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR