BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP RECONSTRUCTION PLATE 10 HOLES/140MM

    MDR report key: 8611556 · Received May 15, 2019

    Report

    Report Number
    2939274-2019-58023
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    April 16, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    10886982169655
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PART 245.101, LOT 8010289: THIS PART NUMBER IS MANUFACTURED IN SWITZERLAND. THE PART/LOT COMBINATION COULD NOT BE VERIFIED AT SYNTHES GMBH, NO DEVICE HISTORY RECORD (DHR) REVIEW WAS POSSIBLE. 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

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE, FOUR (4) CORTEX SCREWS, ONE (1) CANCELLOUS SCREW AND (1) CANNULATED SCREW FROM THE ANKLE DUE TO PAIN. ALL HARDWARE CAME OUT SUCCESSFULLY AND FRACTURES WERE HEALED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING COMPRESSION PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407533 3.5MM LCP RECONSTRUCTION PLATE 10 HOLES/140MM APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 245.101 8010289 10886982169655

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention