BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEM NEUROTUBE

    MDR report key: 3232272 · Received July 12, 2013

    Report

    Report Number
    2183620-2013-00009
    Event Type
    Other
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    JXI
    PMA / PMN Number
    K983007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NEUROTUBE IS INTENDED FOR SINGLE USE IN PATIENT WITH AN INJURY TO A PERIPHERAL NERVE, IN WHICH THE NERVE GAP IS MORE THAN OR EQUAL TO 8 MM, BUT LESS THAN OR EQUAL TO 30 MM. IT WAS NOT REPORTED HOW THE PRODUCT WAS IMPLANTED. HOWEVER, IN THE LETTER OF SYNOVIS, THE PATIENT STATES THAT THERE WAS NO GAP IN NERVE CONTINUITY. THIS SUGGESTS THAT THE PRODUCT WAS USED OFF LABEL. THE PATIENT HAS RESPONDED TO SYNOVIS COMPLAINT INVESTIGATION ASSERTING THAT SHE WILL NOT PROVIDE ANY ADDITIONAL INFORMATION SUCH AS NAME OF HOSPITAL, NAME OR SURGEON, LOT NUMBER, OR ANY DATES OR SURGERIES.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED THE DEVICE MFR, SYNOVIS SURGICAL INNOVATION, REQUESTING INFORMATION REGARDING NEUROTUBE TECHNICAL SPECIFICATIONS AND INSTRUCTIONS FOR USE. THE PATIENT REPORTEDLY HAS ACTIVE DENERVATION AND UNDERWENT SURGERY FOR RELEASE AND DECOMPRESSION OF THE ULNAR NERVE AT THE LEVEL OF ELBOW. THE PROCEDURE INVOLVED ULNAR NERVE ANTERIOR TRANSPOSITION UNDER A FASCIAL FLAP OF THE MEDICAL CONDYLE. DURING A FOLLOW-UP RE-OPERATION, THE NERVE WAS EXPLORED AND WAS FOUND SURROUNDED BY FIBROUS TISSUE IN THE REGION UNDER THE FASCIAL FLAP. THE PATIENT STATES THAT NEUROTUBE MATERIAL WAS PLACED DURING THIS SECOND SURGICAL PROCEDURE IN ORDER TO PROTECT THE ULNAR NERVE. THE PATIENT REPORTS THAT TWO MONTHS LATER, SHE AGAIN PRESENTED WITH ACTIVE DENERVATION. DURING A SECOND RE-OPERATION OF THE ULNAR NERVE SITE, BY A DIFFERENT SURGEON, THE PATIENT ALLEGES THAT THERE WAS NO NEUROTUBE MATERIAL FOUND, THAT IT HAD DISSOLVED AND HAD BEEN ABSORBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321859 GEM NEUROTUBE GEM NEUROTUBE JXI SYNOVIS SURGICAL INNOVATIONS GEM0820NT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other