BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® VA VOLARE DIST. RADIUSPLATE 2.5, BROAD, 5-HOLE, L

    MDR report key: 15562787 · Received October 7, 2022

    Report

    Report Number
    3001406084-2022-00005
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    September 5, 2022
    Report Date
    September 30, 2022
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    UDI-DI
    04042409363221
    PMA / PMN Number
    K153034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTS (PLATE/SCREWS) WERE EXAMINED. ALL PARTS SHOWED NORMAL SIGNS OF USE BUT WERE UNDAMAGED. THE THREADS (PLATE HOLES AND SCREWS) WERE INTACT AND FUNCTIONAL. THE MANUFACTURING AND INSPECTION RECORDS WERE EXAMINED AND SHOWED NO DISCREPANCIES. INQUIRIES WITH THE OPERATOR REVEALED THE FOLLOWING FACTS. A FALL EVENT CANNOT BE RULED OUT AS THE CAUSE, BUT IT CANNOT BE CLEARLY VERIFIED DUE TO THE PATIENT'S DEMENTIA. THERE IS ALSO A PRONOUNCED OSTEOPOROSIS, WHICH WEAKENED THE SCREW-BONE INTERFACE PERMANENTLY. THE REASON FOR THE SECONDARY LOOSENING OF THE SCREWS FROM THE PLATE IS SUSPECTED TO BE THE DISREGARD OF THE FOLLOWING NOTES AND WARNINGS OF THE ACCOMPANYING DOCUMENTATION: "WARNING AAP PRODUCTS MUST NOT BE COMBINED WITH PRODUCTS OF OTHER MANUFACTURERS". AND "MANUAL TIGHTENING TO ENSURE SCREWS PLATE CONNECTION". ACCORDING TO THE SURGEON, THE SCREWS WERE INSERTED BY MACHINE. THE TOOL USED FOR THIS IS NOT PART OF THE INSTRUMENT SET OF THE AAP SYSTEM. THE SCREWS WERE ALSO NOT TIGHTENED MANUALLY AS INTENDED. NO SPECIFICATION DEVIATIONS COULD BE DETECTED ON THE IMPLANT. THE USER DID NOT FOLLOW THE INSTRUCTIONS OF THE SURGICAL TECHNIQUE. THE USER DID NOT CHECK THE SCREW LOCKING.

    Description of Event or Problem · 0

    AFTER TREATMENT OF A DISTAL RADIUS FRACTURE, THE PLATE OSTEOSYNTHESIS FAILED WITHIN 4 WEEKS, RESULTING IN DISLOCATION OF THE SHAFT SCREWS. THE OSTEOSYNTHESIS WAS RESTORED IN A REVISION OPERATION USING A LONGER PLATE. THE TREATED PATIENT (90 YEARS OLD) HAS MULTIPLE COMORBIDITIES (PRONOUNCED OSTEOPOROSIS AND DEMENTIA). THE SURGEON COULD NOT EXCLUDE A FALL EVENT. ON X-RAY ON (B)(6) 2022 LOOSENING OF THE SHAFT SCREWS COULD BE SEEN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555780 LOQTEQ® VA VOLARE DIST. RADIUSPLATE 2.5, BROAD, 5-HOLE, L BONE PLATE HRS AAP IMPLANTATE AG PR2522-05-2 I031 04042409363221

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Hospitalization| R