BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0 VA LOCKNG SCR SLF-TPNG/SD/75

    MDR report key: 12063873 · Received June 24, 2021

    Report

    Report Number
    2939274-2021-03224
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    January 1, 2021
    Report Date
    May 29, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982062222
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRO-CODES: JDP, HWC. WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS PART WAS DISCARDED BY THE FACILITY. (B)(4). INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. DEVICES WERE INVOLVED: 214.836 (4.5MM CORTEX SCREW SELF-TAPPING 36MM), QUANTITY: 3, 02.231.275 (5.0 VA LOCKNG SCR SLF-TPNG/SD/75), QUANTITY: 5-6, A PLATE. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) 5.0 VA LOCKNG SCR SLF-TPNG/SD/75. THIS REPORT IS 8 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960288 5.0 VA LOCKNG SCR SLF-TPNG/SD/75 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.231.275 10886982062222

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention