BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7207006 · Received January 19, 2018

    Report

    Report Number
    2939274-2018-50304
    Event Type
    Injury
    Date Received
    January 19, 2018
    Report Date
    December 22, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PR
    Product Code
    JDP
    UDI-DI
    10886982042873
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NO.: 02.124.413. LOT NO.: L020868, MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: 20.JUN.2016. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC ; DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF ADDITIONAL IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MED-WATCH, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE, AND A FOLLOW-UP MED-WATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A 13 HOLE 4.5 (VARIABLE ANGLE LOCKING PLATE)VA-LCP CONDYLAR PLATE 02.124.413 LOT#L020868 IN (B)(6) 2017. PATIENT REPORTED TO OPERATING ROOM WITH COMPLAINT OF PAIN. X-RAY SHOWED THE PLATE HAD BROKEN BETWEEN THE 3RD AND 4TH SHAFT HOLE DISTALLY DUE TO A DELAYED NON UNION. PLATE WAS REMOVED ON (B)(6) 2017 AND REPLACED WITH A RAFN (RETROGRADE ANTEROGRADE FIXAION NAIL) NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY.NO COMPLICATIONS WERE REPORTED. THIS COMPLAINT IS FOR ONE DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50001 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT IMPLANT,FIXATION DEVICE CONDYLAR PLATE JDP WRIGHTS LANE SYNTHES USA PR 02.124.413 L020868 10886982042873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention