BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES/118MM-RIGHT

    MDR report key: 7140581 · Received December 21, 2017

    Report

    Report Number
    2939274-2017-50400
    Event Type
    Injury
    Date Received
    December 21, 2017
    Report Date
    November 27, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982164476
    PMA / PMN Number
    K052390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW WAS COMPLETED. PART NUMBER: 240.038 LOT NUMBER: H180450 PART MFG DATE: 12-SEP-2016 PART EXP. DATE: N/A (FOR STERILE PRODUCT) MANUFACTURING LOCATION: (B)(6). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 4.5MM LCP PROXIMAL TIBIA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE 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. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE 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. 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 PATIENT IDENTIFIER: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REMOVAL OF A TIBIAL PLATE ON (B)(6) 2017 DUE TO INFECTION. THE PLATE AND EIGHT SCREWS WERE ORIGINALLY IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROXIMAL TIBIA ON (B)(6) 2017. AT THAT TIME, THE PROXIMAL TIBIA PLATE WAS INSERTED WITH NORIAN. THE PATIENT WAS RETURNED TO SURGERY FOR INFECTION AND REMOVAL OF HARDWARE. THE SURGEON REMOVED AS MUCH NORIAN AS POSSIBLE WITH A CURETTE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY, AND NO REPORTED FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS REPORTED AS OKAY. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917891 4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES/118MM-RIGHT PLATE, FIXATION, BONE HRS WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 240.038 H180450 10886982164476

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention