BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM

    MDR report key: 11046549 · Received December 21, 2020

    Report

    Report Number
    2939274-2020-05659
    Event Type
    Injury
    Date Received
    December 21, 2020
    Report Date
    November 24, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982166890
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART NUMBER: 241.371, LOT NUMBER: 9919494, PART MANUFACTURING DATE: 13 OCTOBER 2015, MANUFACTURING SITE: (B)(4), PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9919494 OF LCP ONE-THIRD TUBULAR PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 7980684 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 AN UNKNOWN DATE THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF A LOCKING COMPRESSION PLATE (LCP) ONE THIRD TUBULAR PLATE AND SCREWS DUE TO A RECURRENT INFECTION. THERE WAS NO ALLEGATION WITH THE HARDWARE THAT WAS IMPLANTED IN 2015. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. ALL OF THE HARDWARE WAS REMOVED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514743 LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 241.371 9919494 10886982166890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention