BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM PRE-BENT WEDGE VL GRIDLOCK PLATE

    MDR report key: 7073118 · Received November 30, 2017

    Report

    Report Number
    3007420745-2017-00015
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 30, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    PMA / PMN Number
    K130964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 300-54-106 PLATE WAS BROKEN IN A PATIENT THAT HAD UNDERGONE SURGERY EARLIER IN 2017. THE PATIENT CAME IN FOR A FOLLOW-UP AND UPON EXAMINATION, THE PLATE WAS PALPABLE THROUGH THE PATIENT'S SKIN. THE SURGEON BELIEVED THE SURGICAL SITE DID NOT FEEL AS HE WOULD LIKE, SO AN X-RAY OF THE SITE WAS PERFORMED. UPON REVIEWING THE X-RAY, THE SURGEON NOTICED THAT THE 300-54-106 PLATE WAS BROKEN. A FUSION HAD NOT OCCURED AND THE PLATE WAS REMOVED ON (B)(6)2017. A 300-50-004 AND 300-55-004 PLATE WAS USED IN THE REVISION SURGERY IN PLACE OF THE BROKEN 300-54-106 PLATE THAT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852830 5MM PRE-BENT WEDGE VL GRIDLOCK PLATE BONE PLATE HRS TRILLIANT SURGICAL, LTD TSL004157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention