BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PROXIMAL TIBIA LISS PLATE 13 HOLES/300MM-LEFT

    MDR report key: 4027060 · Received August 21, 2014

    Report

    Report Number
    3009450884-2014-10054
    Event Type
    Injury
    Date Received
    August 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK962047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT REPORTED AS (B)(6) 2014; IT IS UNKNOWN IF THAT IS WHEN THE PLATE BROKE OR WHEN IT WAS DISCOVERED BROKEN. (B)(6). 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 COMMON DEVICE NAME: HWC. LOT NUMBER REPORTED ONLY AS 782392, THE LOT HAS BEEN CONFIRMED TO BE 7823927. (B)(4). NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PATIENT HAD A SKIING ACCIDENT ON (B)(6) 2014. THE PATIENT HAD A FRACTURE ON HIS LEFT LEG AND GOT AN EXTERNAL FIXATOR. ON (B)(6) 2014 SURGERY TOOK PLACE TO REMOVE THE EXTERNAL FIXATOR AND IMPLANT A PLATE AND LAG SCREW. ON (B)(6) 2014, THE PATIENT UNDERWENT A CLOSED REDUCTION AND INTERNAL FIXATION WITH A LISS PLATE. SEVERAL PLASTIC SURGERY PROCEDURES WERE ALSO PERFORMED. THE PATIENT REMAINED IN THE HOSPITAL FROM (B)(6) 2014. THE PATIENT THEN WAS TRANSFERRED FOR FOLLOW UP CARE. THE PLATE BROKE POST-OPERATIVELY AND WAS REVISED ON (B)(6) 2014. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN RELATED TO THE BROKEN PLATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN X-RAY CONFIRMED A BROKEN PLATE OF THE LEFT TIBIA, BELIEVED TO HAVE BEEN CAUSED BY THE PATIENT NOT FOLLOWING DISCHARGE INSTRUCTIONS OF PARTIALLY BURDEN WEIGHT ON THE FRACTURED LEG. THE PATIENT WAS REPORTED TO HAVE FULLY WEIGHT BURDENED THE FRACTURED/PLATED LEG. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507018 TI PROXIMAL TIBIA LISS PLATE 13 HOLES/300MM-LEFT NAIL, FIXATION, BONE HRS SYNTHES GRENCHEN 7823927

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention