BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIBLOC RIB FRACTURE PLATING SYSTEM

    MDR report key: 2919864 · Received January 11, 2013

    Report

    Report Number
    3005670412-2013-00001
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    October 15, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ACUTE INNOVATIONS
    Product Code
    HRS
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER INVESTIGATION, FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    WHILE FIXING A POSTERIOR RIB FRACTURE, THE SURGEON STRUGGLED TO MATCH THE CORRECT CONTOUR AND HAD TO BEND THE PLATE SEVERAL TIMES. THE SURGEON DID NOT FOLLOW CONTOURING INSTRUCTION AND INSTEAD USED STANDARD EVENTUALLY INSTALLED. ON POST-OP DAY TWO, AN X-RAY SHOWED THAT THE PLATE HAD BROKEN. THE PLATE WAS REMOVED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16374 RIBLOC RIB FRACTURE PLATING SYSTEM RIB BONE PLATE HRS ACUTE INNOVATIONS RBP1122 L1102015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention