BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LC-DCP® PLATE 6 HOLES/77MM

    MDR report key: 7450611 · Received April 23, 2018

    Report

    Report Number
    2939274-2018-51849
    Event Type
    Injury
    Date Received
    April 23, 2018
    Report Date
    April 3, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982157904
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL IMPLANT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PATIENT CODE (B)(4) USED FOR: THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. DEVICE HISTORY RECORDS REVIEW NOT AVAILABLE TO REPORT AT THIS TIME. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. 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

    PATIENT HEIGHT REPORTED AS 5¿2¿. ADDITIONAL PATIENT IDENTIFIER: (B)(6), DHR REVIEW WAS COMPLETED. PART NUMBER: 223.56, LOT NUMBER: 6243738, PART MANUFACTURE DATE: 22-OCT-2009 , MANUFACTURING LOCATION: (B)(4), PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 3.5MM LC-DCP PLATE 6 HOLES/77MM PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL 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. CORRECTED DATA: INITIAL REPORTER TELEPHONE AND EMAIL. 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 A PATIENT HEALED AND CONTACTED THE HOSPITAL TO HAVE THE HARDWARE REMOVED. ON (B)(6) 2018, A 3.5MM LC-DCP PLATE AND 6 CORTICAL SCREWS WERE REMOVED SUCCESSFULLY. REASON FOR REMOVAL OF HARDWARE WAS DUE TO THE PATIENT PRESENTING WITH A SLIGHT PROMINENCE OF THE IMPLANTS. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FRAGMENTS WERE GENERATED DURING THE PROCEDURE. THE PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295296 3.5MM LC-DCP® PLATE 6 HOLES/77MM PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 223.56 6243738 10886982157904

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention