BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT

    MDR report key: 8408699 · Received March 11, 2019

    Report

    Report Number
    8030965-2019-61875
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 14, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWT
    UDI-DI
    07611819418981
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART 03.812.308, LOT 9086959: MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: OCTOBER 16, 2014. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE RECEIVED INSTRUMENT IS ALL IN ALL IN GOOD CONDITION THERE ARE SOME WEAR MARKS AT THE COUPLING VISIBLE. ADDITIONALLY THE WELD ON THE INSTRUMENT IS BROKEN AND THEREFORE THE TWO PARTS CAN BE DISMANTLED INTO TWO PIECES. THE RELEVANT DIMENSIONS WERE MEASURED AND PASSED. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. THE MICROSCOPIC INVESTIGATION AFTER THE WELDING PROCEDURE HAS SHOWN NO DEVIATIONS TO THE SPECIFICATION. A 100 % FUNCTIONAL TEST AND VISUAL INSPECTION WAS PERFORMED AND HAS SHOWN NO DEVIATIONS TO THE SPECIFICATION. THE RECEIVED INSTRUMENT IS ALL IN ALL IN GOOD CONDITION THERE ARE SOME WEAR MARKS AT THE COUPLING VISIBLE. ADDITIONALLY THE WELD ON THE INSTRUMENT IS BROKEN AND THEREFORE THE TWO PARTS CAN BE DISMANTLED INTO TWO PIECES. THE RECEIVED CONDITION OF THE ITEM IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THIS LOT OF DEVICES WAS MANUFACTURED IN OCTOBER 2014 ACCORDING TO THE SPECIFICATION. BASED ON THAT AND THE CONDITION OF THE ITEM A PRODUCT RELATED ISSUE CAN BE EXCLUDED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOADING SITUATION FOR EXAMPLE AXIAL MOVEMENT HAS CAUSED THE BREAKAGE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE WAS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE THE PART OF THE LUMBAR T-PAL LONG SHAFT OF THE TRIAL IMPLANT WAS FOUND LOOSE AND GOT STUCK IN THE UNKNOWN IMPLANT HOLDER. AFTER THE SURGERY WAS DONE THE INSTRUMENT WAS INSPECTED TO FIND OUT WHY THERE WAS TROUBLE WITH GETTING THE TRIAL IMPLANT OUT OF THE UNKNOWN INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER INSTRUMENT AND SETTING THE IMPLANT WITH ANOTHER ONE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. WHEN THE DEVICES WERE BEING INVESTIGATED BY THE MANUFACTURER, IT WAS NOTED THE WELD ON THE T-PAL TRIAL SPACER IS BROKEN AND THEREFORE THE TWO PARTS CAN BE DISMANTLED INTO TWO PIECES. THIS REPORT IS FOR A T-PAL TRIAL SPACER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201673 T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT TEMPLATE HWT OBERDORF SYNTHES PRODUKTIONS GMBH 9086959 07611819418981

    Patients

    Seq Age Sex Outcome Treatment
    1