BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC 155MM U PLUS RIB PLATE

    MDR report key: 7778555 · Received August 13, 2018

    Report

    Report Number
    3005670412-2018-00008
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 19, 2018
    Report Date
    July 17, 2018
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    HRS
    UDI-DI
    10814493010401
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD RIB PLATE INSTALLED ABOUT A YEAR AGO (2017) AS PART OF A CHEST WALL RECONSTRUCTION. THE PLATE BROKE AND REVISION SURGERY WAS PERFORMED TO REMOVE THE PLATE. ADDITIONALLY THERE WAS SOME WIRE USED TO WRAP AROUND THE PLATE AND BONE, THIS WIRE IS NOT PART OR ACUTE PRODUCT LINE. THE RIB PLATE AND FOUR SCREWS WERE REMOVED. THE BROKEN EDGES OF THE PLATE WERE BENT, DEFORMED AND WORN SMOOTH, INDICATING THAT THE EDGES LIKELY RUBBED AGAINST EACH OTHER. THE SCREW HEADS SHOWED SOME WEAR LIKELY FROM THE WIRE RUBBING ON THE SCREW HEADS, OTHERWISE SCREWS WERE UNDAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617272 RIBLOC 155MM U PLUS RIB PLATE U PLUS RIB PLATE HRS ACUTE INNOVATIONS LLC RBL1304 L1504005 10814493010401

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention