BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL-HOLDER F/SYNFIX-LR

    MDR report key: 2994205 · Received March 8, 2013

    Report

    Report Number
    8030965-2013-00787
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATIONS HAVE SHOWN THAT THE TIP IS INDEED BROKEN OFF. UNFORTUNATELY WE ARE NOT ABLE TO COMPREHEND HOW THIS BREAKAGE OCCURRED. WE CAN ONLY SUPPOSE THOUGH THAT THE SCREWDRIVER HAD NOT BEEN SCREWED IN DEEP ENOUGH INTO THE CAGE AND THAT THE TIP BROKE OFF DURING HAMMERING. OR THE SURGEON APPLIED TOO MUCH MECHANICAL FORCE AS HE EXPERIENCED DIFFICULTY UNCOUPLING IT FROM THE IMPLANT. THE BROKEN SURFACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, DURING INSERTION OF THE SYNFIX CAGE THE THREADED TIP OF THE SYNFIX IMPLANT HOLDER BROKE OFF IN-SITU WHILE ATTACHED TO THE IMPLANT. REPORTEDLY THE SURGEON FELT DIFFICULTY UNCOUPLING THE INSTRUMENT AND THE IMPLANT. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98949 IMPL-HOLDER F/SYNFIX-LR LXH SYNTHES GMBH 2701876

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR