BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI LCP(TM) PROX TIBIA PLATE 12H/226MM/LEFT-STERILE

    MDR report key: 12804576 · Received November 12, 2021

    Report

    Report Number
    8030965-2021-09469
    Event Type
    Injury
    Date Received
    November 12, 2021
    Report Date
    October 19, 2021
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    07611819764545
    PMA / PMN Number
    K052390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A J&J REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE 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 HISTORY LOT: PART: 440.045S, LOT: L873502, MANUFACTURING SITE: (B)(4). SUPPLIER: N/A. RELEASE TO WAREHOUSE DATE: 25 MAY 2018. EXPIRATION DATE: 01 MAY 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TIBIAL PLATEAU. THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE SURGERY, ON AN UNKNOWN DATE, IT WAS FOUND THE SURFACE OF THE SKIN WHERE THE PLATE WAS PLACED WAS TURN INTO RED AND PATIENT HAD SYMPTOMS SUGGESTIVE OF METAL ALLERGY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM TI LCP(TM) PROX TIBIA PLATE 12H/226MM/LEFT-STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705726 4.5MM TI LCP(TM) PROX TIBIA PLATE 12H/226MM/LEFT-STERILE PLATE, FIXATION, BONE HRS WRIGHTS LANE : SYNTHES USA PRODUCTS LLC L873502 07611819764545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention LCP PROXIMAL TIBIAL PL 4.5/5 LAT LE SHAF| UNK - SCREWS: CANCELLOUS| UNK - SCREWS: CORTEX| UNK - SCREWS: LOCKING