BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP PROXIMAL LATERAL TIBIA PLATE 11 HOLES/260MM-RIGHT

    MDR report key: 12561940 · Received October 1, 2021

    Report

    Report Number
    8030965-2021-08227
    Event Type
    Injury
    Date Received
    October 1, 2021
    Report Date
    September 2, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    10886982156631
    PMA / PMN Number
    K052390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PART: 222.226, LOT: 9122967, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: SEPTEMBER 02, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A (RIGHT) PROXIMAL LATERAL TIBIAL PLATE REVISION DUE TO PAIN AND NON-UNION. PROXIMAL SCREWS HAD BACKED OUT. PATIENT WAS REVISED WITH A VARIABLE ANGLE (VA) PROXIMAL LATERAL TIBIAL PLATE AND A MEDIAL PLATE. PATIENT WAS ORIGINALLY TREATED ON (B)(6) 2021, FOR A PROXIMAL TIBIAL FRACTURE. THIS REPORT IS FOR A LOCKING COMPRESSION PLATE (LCP) PROXIMAL LATERAL TIBIA PLATE. THIS IS REPORT 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461209 LCP PROXIMAL LATERAL TIBIA PLATE 11 HOLES/260MM-RIGHT PLATE, FIXATION, BONE HRS SYNTHES GMBH 222.226 9122967 10886982156631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKSCR Ø5 SELF-TAP L34 SST.| LOCKSCR Ø5 SELF-TAP L55 SST.| LOCKSCR Ø5 SELF-TAP L65 SST.| LOCKSCR Ø5 SELF-TAP L65 SST.| LOCKSCR Ø5 SELF-TAP L80 SST.| UNK - SCREWS: TRAUMA.| LOCKSCR Ø5 SELF-TAP L34 SST| LOCKSCR Ø5 SELF-TAP L55 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L80 SST| UNK - SCREWS: TRAUMA