BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SPACER APPLICATOR HANDLE

    MDR report key: 2874227 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01586
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AN EXACT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. EXCESSIVE HAMMERING COULD HAVE CAUSED OVER ROTATION OF THE IMPLANT RESULTING IN DIFFICULTY DETACHING THE IMPLANT FROM THE DEVICE. THE IMPLANT IN THIS CASE WAS NOT RETURNED AND THEREFORE CANNOT BE EVALUATED WITH THE RETURNED MATING INSTRUMENT. THE MATING INSTRUMENT WAS DEFORMED PAST THE POINT WHERE IT CAN BE TESTED WITH A SPACER. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NO VISIBLE DAMAGES, EXCEPT SOME SIGNS USE, LIKE SCRATCHES AND SLIGHT NICKS. A FUNCTION TEST ACCORDING TO THE TEST INSTRUCTIONS SE 257044 AND SE 256859 WAS PERFORMED AND THE DEVICE WAS FUNCTIONAL AS REQUIRED. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2011, THE SURGEON HAD COMPLETED THE DISCECTOMY, TRIALED THE SPACE AND PLACED A T-PAL SPACER. AS THE SURGEON ATTEMPTED TO REMOVE THE APPLICATOR THE INNER SHAFT WOULD NOT RELEASE THE IMPLANT. THE SURGEON TRIED FOR 35 MINUTES AND ENDED UP DESTROYING THE INNER SHAFT TO GET IT TO RELEASE THE IMPLANT. AFTER THE RELEASE THE IMPLANT WAS NO LONGER SET PERFECTLY. AFTER 10 MINUTES THE SURGEON WAS UNABLE TO ADJUST THE IMPLANT TO WHERE HE WANTED IT. THE IMPLANT WAS LEFT IN THE PATIENT. THE SURGEON WAS SURE THE IMPLANT HAD NOT BEEN DAMAGED EVEN THOUGH HE WAS NOT HAPPY WITH ITS PLACEMENT. HE DID NOT FEEL THE PLACEMENT CAUSED ANY DANGER TO THE PATIENT. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-PAL SPACER APPLICATOR HANDLE T-PAL SPACER APPLICATOR HANDLE LXH SYNTHES GMBH 3481537

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention INNER SLEEVE