BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/61MM

    MDR report key: 2931044 · Received January 28, 2013

    Report

    Report Number
    3003506883-2013-00039
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT SUFFERED A DISTAL TIBIA FRACTURE AND WAS IMPLANTED WITH ONE-THIRD TUBULAR PLATE WITH COLLAR, LC-DCP 8 HOLE PLATE, MEDIAL DISTAL TIBIA PLATE, LC-DCP 4 HOLE PLATE, AND CORTEX SCREW CONSTRUCT ON (B)(6), 2011. ON AN UNKNOWN DATE, PATIENT REPORTED PAIN AT IMPLANT SITE. PATIENT RETURNED TO THE OR ON (B)(6), 2013 FOR REMOVAL OF HARDWARE. IT IS REPORTED THAT PATIENT WAS HEALED AND WAS NOT REVISED WITH ANY OTHER HARDWARE.THIS IS 1 OF 17 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36433 ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/61MM ONE-THIRD TUBULAR PLATE WITH COLLAR HRS SYNTHES ELMIRA 6622855

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention