BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PLIF IMPLANT HOLDER

    MDR report key: 4316672 · Received December 10, 2014

    Report

    Report Number
    9680938-2014-10093
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION: ONE T-PLIF IMPLANT HOLDER (PART 03.806.000, LOT T957505, MFG APR 2011) WAS RETURNED WITH THE COMPLAINT THAT ¿THE T-PLIF IMPLANT HOLDER WAS ROTATING DURING INSERTION. A SMALL TEAR OCCURRED IN THE DURA AS A RESULT OF THE IMPLANT HOLDER ROTATING.¿ UPON RECEIPT OF THE DEVICE, THE IMPLANT HOLDER WAS FOUND TO BE INTACT AND IN GOOD CONDITION, WITH MOVING PARTS FUNCTIONING AS INTENDED, AND IS ABLE TO HOLD THE IMPLANT WITH WHICH IT WAS RETURNED (08.804.010) SECURELY AND RELEASES IT AS DESIGNED; NO ROTATIONAL MOVEMENT COULD BE DISCERNED. THIS COMPLAINT IS UNCONFIRMED. THE DRAWINGS FOR THIS DEVICE WERE REVIEWED, NO DISCREPANCIES WERE FOUND BETWEEN THE DRAWING SPECIFICATIONS AND THE RETURNED DEVICE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. THIS COMPLAINT CONDITION IS UNCONFIRMED, THIS COMPLAINT COULD HAVE OCCURRED IF THE SPEED NUT WAS NOT TIGHTENED, THUS NOT HOLDING THE IMPLANT STABLE DURING INSERTION, AS BOTH THE IMPLANT AND IMPLANT HOLDER WERE FOUND TO BE IN GOOD WORKING CONDITION THIS COMPLAINT WAS LIKELY A RESULT OF USER ERROR. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SMALL TEAR IN THE DURA AS A RESULT OF THE IMPLANT HOLDER ROTATING. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #KR322626 AND #221302 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 49HRC AND WAS FOUND TO BE GOOD. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE T-PLIF IMPLANT HOLDER WAS ROTATING DURING INSERTION WHILE THE SURGEON WAS PERFORMING A 4-5 TRANSFORAMINAL POSTERIOR LUMBAR INTER-BODY FUSION PROCEDURE (T-PLIF) ON (B)(6) 2014. REPORTEDLY THE T-PLIF IMPLANT HOLDER WAS ROTATING DURING INSERTION AND A SMALL TEAR OCCURRED IN THE DURA AS A RESULT OF THE IMPLANT HOLDER ROTATING, THE SURGEON SEWED UP THE DURA AND THEN CONTINUED WITH THE SURGERY. THERE WAS A 15 MINUTE TIME DELAY TO SEW UP THE PATIENT ANOTHER T-PLIF IMPLANT HOLDER WAS NOT AVAILABLE, SO THAT SURGEON USED AN OBLIQUE POSTERIOR ATRAUMATIC LUMBAR (OPAL) SPACER TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS A 5 MINUTE TIME DELAY TO SWITCH FROM THE T-PLIF TO THE OPAL SPACER. THERE WAS A TOTAL DELAY OF 20 MINUTES IN THE SURGERY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798869 T-PLIF IMPLANT HOLDER FORCEPS HTD SYNTHES TUTTLINGEN T957505

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention