BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT

    MDR report key: 9756676 · Received February 26, 2020

    Report

    Report Number
    2939274-2020-01055
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    February 5, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDP
    UDI-DI
    10886982042835
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: D7: UPDATED. E1: INITIAL REPORTER INFO UPDATED. H3, H6: INVESTIGATION SUMMARY. 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: 02.124.411. LOT: L920894. MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: (B)(6) 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: HRS, HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO A BROKEN VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED EIGHT (8) MONTHS AGO. THE VA-LCP CURVED CONDYLAR PLATE ALONG WITH THREE (3) CORTICAL SCREWS, FIVE (5) LOCKING SCREWS, AND ONE (1) NON-LOCKING SCREW WERE REMOVED AND REPLACED WITH A 2-HOLE LONGER PLATE. THE SURGERY WAS COMPLETED WITH NO HARM TO THE PATIENT. CONCOMITANT DEVICES: CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 3), LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 5), SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220748 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.124.411 L920894 10886982042835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWS: CORTEX| UNK - SCREWS: LOCKING| UNK - SCREWS: TRAUMA