BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOQTEQ STRAIGHT PLATE 3.5 8 HOLES, L112

    MDR report key: 3963474 · Received June 18, 2014

    Report

    Report Number
    8043862-2014-00007
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WITH REGARD TO THE ASSESSMENT AAP IS CONVINCED THAT THE SCREW LOOSENING IS NOT AN ISSUE OF THE DESIGN OF THE LOQTEQ PLATING SYSTEM. FURTHERMORE THE DOCUMENTATION OF PRODUCTION AND QUALITY CONTROL SHOWS THAT THE DEVICES WERE WITHIN SPECS. THE MECHANICAL TEST WHICH WAS PERFORMED FOR THE SCREWS HAS SHOWN A DIFFERENT FAILURE MODE THAT THE COMPETITOR'S PRODUCT. THE UNSTABLE FRACTURE SITUATION WITH A HIGH LOAD ON THE ANGLE STABLE CONNECTION BETWEEN PLATE AND SCREWS SUPPORTS THE LOOSENING OF THE SCREWS AND WITH REGARD TO THE TEST RESULTS THIS FAILURE MODE WAS EXPECTED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT WITH 20-YEAR OLD TRAUMATIC NON-UNION. PREVIOUS HUMERUS SHAFT TRAUMA 20 YEARS AGO WAS TREATED WITH DCP PLATE (NON-LOCKING), BUT DIDN'T HEAL. THE PLATE WAS IN SITU FOR 20 YEARS, AND BROKE CA. 2 MONTHS AGO. A REVISION SURGERY WITH 2 X LOQTEQ STRAIGHT PLATES 3.5 WAS CARRIED OUT IN A PRIVATE HOSPITAL. TWO LOQTEQ PLATE WERE USED - 8 HOLE AND 9 HOLE. THE SURGEON ACKNOWLEDGED THAT NORMALLY FOR THIS INDICATION HE WOULD USE 4.5MM PLATES, BUT BECAUSE PT'S BONE WAS SMALL AND LOQTEQ STRAIGHT SMALL FRAGMENT PLATES ARE QUITE THICK, HE THOUGHT TWO LOCKING PLATES SHOULD BE SUFFICIENT. NO BONE GRAFT WAS USED. TORQUE LIMITER WAS USED FOR ALL SCREWS. THE PT PRESENTED CA. 2 MONTHS LATER. THE BONE DIDN'T HEAL AND INFECTION IS SUSPECTED. X-RAYS SHOWS THAT LOCKING LOQTEQ PLATES HAVE LOOSENED AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2014. THE SURGEON'S CONCERN WAS THAT THE LOCKING SCREWS HAVE LOOSENED. THE SURGEON MENTIONED THAT THIS IS A DIFFICULT CASE AND HE WAS NOT SURPRISED THAT THE BONE DIDN'T HEAL. IF THE IMPLANT WERE TO FAIL, HE EXPECTED THE MECHANISM OF FAILURE TO BE EITHER BY BACKING OUT OF THE WHOLE PLATE/SCREW CONSTRUCT OUT OF THE BONE OR SCREW HEAD BREAKAGE. HE DIDN'T EXPECT SCREW LOOSENING. 7 OUT OF 13 SCREWS APPEARED TO BE LOOSE. THE SCREW NEXT TO THE PLATE WAS CONTOURED WITH THE BENDING PLIERS FROM LOQTEQ TRAY TO ADAPT TO THE BONE. THE 8 HOLE PLATE WAS NOT CONTOURED. THE LOQTEQ IMPLANTS WERE REMOVED. THE REVISION WAS CARRIED OUT WITH A SHAFT NAIL ILLUMINOSS AS A MEANS OF STABILIZING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358472 LOQTEQ STRAIGHT PLATE 3.5 8 HOLES, L112 BONE PLATE HRS AAP IMPLANTATE AG PG 3555-08-2 K054

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention