BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT

    MDR report key: 8374750 · Received February 27, 2019

    Report

    Report Number
    2939274-2019-56700
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 2, 2019
    Report Date
    February 2, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982042873
    PMA / PMN Number
    K110354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: JDP AND HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON NOTED THAT THE CANNULATED VARIABLE LOCKING SCREW DID NOT LOCK INTO DISTAL HOLE AND THE SURGEON ALSO MENTIONED IT MAY HAVE STRIPPED THE THREADS ON THE VARIABLE ANGLE- LOCKING CONDYLAR PLATE DURING SCREW INSERTION. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A VARIABLE ANGLE- LOCKING CONDYLAR PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167510 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.124.413 10886982042873

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR