BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME LENGTHENER

    MDR report key: 2882297 · Received December 20, 2012

    Report

    Report Number
    8030965-2012-01622
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    K993314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ACCORDING TO THE DRAWING THE SLOTTED SCREW IS FIXED WITH LOCTITE IN THE FIXATION SCREW. AFTERWARDS IT IS IMPOSSIBLE TO DETERMINE FROM A MANUFACTURING STANDPOINT IF THIS LOCTITE WAS APPLIED IN A SUFFICIENT AMOUNT AND ON THE WHOLE SURFACE. THERE ARE NO RESIDUES OF LOCTITE VISIBLE AT THE THREAD, BUT THIS WAS PROBABLY WASHED AWAY DURING THE DECONTAMINATION OF THE DEVICE. HOWEVER, THIS WAS OBVIOUSLY AN OVER YEARS OFTEN AND INTENSE USED DEVICE, WHICH INDICATES THAT THE SCREW WAS SECURED AS REQUIRED BACK THEN.

    Description of Event or Problem · 1

    DURING AN L5-S1 ALIF PROCEDURE, THE SYNFRAME RING PIECE OF THE SYNFRAME HALF RING THAT SCREWS AND HOLDS THE NUTS TOGETHER FELL OFF AS WELL AS THE NUTS. THE TWO NUTS THAT FELL OUT OF THE SYNFRAME RING PIECE THE SYNFRAME HALF RING WERE RETRIEVED AND DID NOT FALL INTO PATIENT. THE SURGEON WAS ABLE TO LOCK THE RING DOWN SECURELY. ONE OF THE COLD WELD PIECES ON THE SYNFRAME LENGTHENER ALSO CAME APART DURING THE PROCEDURE. WHILE INSERTING THE PROACCESS RADIOLUCENT BLADES INTO THE HOLDER, THE BLADES BENT. THE PROCEDURE WAS NOT PROLONGED DUE TO THIS INCIDENT. THE SURGEON WAS ABLE TO USE BACK UP DEVICES TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS IS 6 OF 6 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNFRAME LENGTHENER SYNFRAME LENGTHENER LXH SYNTHES GMBH 1589655

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR BLADES, HALF RINGS