BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP® METAPHYSEAL PLATE 12 HOLES

    MDR report key: 8922616 · Received August 22, 2019

    Report

    Report Number
    8030965-2019-67650
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    July 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXT
    UDI-DI
    07611819282735
    PMA / PMN Number
    K033805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART: 423.412S; LOT: L980401; MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: JULY 27, 2018. EXPIRY DATE: JULY 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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. (B)(4). 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) 2018, THE PATIENT UNDERWENT A MALIGNANT TUMOR REMOVAL SURGERY FOR FEMORAL FRACTURE WITH PEDIATRIC HIP PLATE AND METAPHYSEAL PLATE WITH 12 HOLES (FIRST PLATE). ON (B)(6) 2019, THE METAPHYSEAL PLATE WAS REPLACED WITH ANOTHER METAPHYSEAL PLATE WITH 14 HOLES (SECOND PLATE) BECAUSE THE INITIAL PLATE HAD BROKEN. ON (B)(6) 2019, THE SECOND METAPHYSEAL PLATE WAS REPLACED WITH A NEW PLATE BECAUSE THE SECOND PLATE HAD BROKEN AS WELL. CONCOMITANT DEVICES: LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 3.5MM TITANIUM (TI) LOCKING COMPRESSION PLATE (LCP)® METAPHYSEAL PLATE 12 HOLES. THIS IS REPORT 1 OF 1 FOR (B)(6) AND CAPTURES THE BREAKAGE OF THE FIRST METAPHYSEAL PLATE. RELATED (B)(6) CAPTURES THE BREAKAGE OF THE SECOND PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713424 3.5MM TI LCP® METAPHYSEAL PLATE 12 HOLES APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM LXT OBERDORF SYNTHES PRODUKTIONS GMBH L980401 07611819282735

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention