BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7119028 · Received December 14, 2017

    Report

    Report Number
    2939274-2017-50270
    Event Type
    Injury
    Date Received
    December 14, 2017
    Report Date
    November 17, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. IT IS UNKNOWN WHEN THE TISSUE IRRITATION BEGAN. IMPLANT DATE: UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. PART NUMBER: 241.371. LOT NUMBER: H040984. PART MANUFACTURE DATE: 25-FEB-2016. MANUFACTURING LOCATION: (B)(4). PART EXPIRATION DATE: N/A. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED 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. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARDWARE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE A ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49 MM, A LOCKING COMPRESSION PLATE ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81 MM, EIGHT (4.0 MM) CANCELLOUS SCREWS, AND THREE (3.5 MM) CORTEX SCREWS. THE INITIAL SURGERY DATE IS UNKNOWN BUT IT WAS FOR A FIBULA FRACTURE. THE HARDWARE REMOVAL WAS DUE TO SOFT TISSUE IRRITATION. THERE WERE NO MALFUNCTIONS WITH THE HARDWARE REMOVED, NO SURGICAL DELAYS AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH PATIENT OUTCOME NOTED AS STABLE. X-RAYS WERE TAKEN BUT UNAVAILABLE TO BE SENT. NO ADDITIONAL IMPLANTS OR MEDICAL INTERVENTIONS WERE PERFORMED ON PATIENT POST HARDWARE REMOVAL. THIS COMPLAINT INVOLVES 13 PARTS. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896533 LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM PLATE, FIXATION, BONE HRS WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 241.371 H040984 10886982166890

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention