BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOQTEQ® BROAD PLATE 4.5, 16 HOLES, L 293

    MDR report key: 18037635 · Received October 31, 2023

    Report

    Report Number
    3001406084-2023-00006
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    August 29, 2023
    Report Date
    October 5, 2023
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HRS
    PMA / PMN Number
    K113648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLIANCE WITH THE KNOWN RULES OF OSTEOSYNTHESIS, WHICH MUST BE CONSIDERED AS A BASIS FOR THE USE OF THE PLATE SYSTEM, DID NOT OCCUR. THE FOLLOWING RULE WERE NOT OBSERVED: TWO CRITERIA ARE USED WHEN SELECTING THE LENGTH OF LOCKING PLATES: WORKING LENGTH AND TOTAL LENGTH. THE WORKING LENGTH IS THE DISTANCE BETWEEN THE FIRST TWO LOCKING SCREWS LOCATED ON EITHER SIDE OF THE FRACTURE SITE. THIS IS THE AREA ON WHICH THE STRESSES ACT. IT DETERMINES THE STIFFNESS OF THE CONSTRUCT. THE CONSTRUCT MUST BE STIFF AND AT THE SAME TIME ELASTIC TO ALLOW THE MICRO-MOVEMENT NECESSARY FOR HEALING. IN A FRACTURE, LEAVING THREE OR FOUR EMPTY HOLES OVER THE FRACTURE SITE WILL RESULT IN THE DESIRED ELASTICITY OF THE CONSTRUCT. THIS WAS NOT THE CASE IN THE PRESENT CASE. AN IMPLANT-BASED CAUSE COULD NOT BE PROVEN.

    Description of Event or Problem · 0

    AN OSTEOSYNTHESIS PLATE FRACTURED APPROXIMATELY 5 MONTHS AFTER IMPLANTATION IN THE ABSENCE OF FRACTURE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123849 LOQTEQ® BROAD PLATE 4.5, 16 HOLES, L 293 BONE PLATES HRS AAP IMPLANTATE AG PG 4556-16-2 K083

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention