BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC RIB FRACTURE PLATING SYSTEM

    MDR report key: 3022649 · Received March 21, 2013

    Report

    Report Number
    3005670412-2013-00004
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ACUTE INNOVATIONS
    Product Code
    HRS
    PMA / PMN Number
    K113318
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ACUTE INNOVATIONS REP ATTENDED A RIB PLATE REMOVAL CASE. PT HAD REPORTED PAIN, PRESUMABLY DUE TO HIS RIB PLATES INITIALLY IMPLANTED IN (B)(6) 2011. THE SURGEON NOTED THAT THIS PT HAD ELBOW PLATES [NONE ACUTE INNOVATIONS PRODUCT] ALSO IMPLANTED AND THAT HE EXPERIENCED PAIN FROM THOSE IMPLANTS AND CHOOSE TO HAVE THEM REMOVED. THE PT REPORTED PAIN RELIEF FROM REMOVAL OF THE ELBOW PLATES. THE SURGEON REMOVED 5 RIBLOC RIB FRACTURE PLATES AND ASSOCIATED SCREWS AND 2 COMPETITOR RIB PLATES AND ASSOCIATED SCREWS. SURGEON REPORTED THAT ALL FRACTURES HAD HEALED. AND REMOVAL OF ALL RIBLOC PLATES AND SCREWS WAS SUCCESSFULLY ACCOMPLISHED WITHOUT INCIDENT. MODEL #S RBP 1122 (QTY 1), 1101 (QTY 2), 1102 (QTY 1), 1201 (QTY 12), 1202 (QTY 8) AND 1212 (QTY 2). LOT #S: RIB FRACTURE PLATES L0906037, L0906037, L1009006, L0906045, L0908001. PRIMARY SCREWS L1102004, L1102010, L0906024. INTERMEDIATE SCREWS L0906030, L1105011.

    Description of Event or Problem · 1

    PLATE AND SCREW REMOVAL DUE TO IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117233 RIBLOC RIB FRACTURE PLATING SYSTEM RIB BONE PLATE HRS ACUTE INNOVATIONS RBP1121 (QTY 1) L1102015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention