BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PLATE

    MDR report key: 24945002 · Received April 21, 2026

    Report

    Report Number
    0001032347-2026-00098
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: D1 - 12 HOLE LADDER PLATE. D4 - CATALOG NUMBER - 73-2632. G4 - K161896. OR THE PART/LOT INFORMATION COULD BE: D1 - RIBFIX BLU 12 HOLE PLATE. D4 - CATALOG NUMBER - 76-2602. G4 - K162974. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 73-4210(UNKNOWN) QTY: 8. 76-2414(UNKNOWN) QTY: 4. 76-2416(UNKNOWN) QTY: 8. 73-2412(UNKNOWN) QTY: 8. 76-2408(UNKNOWN) QTY: 35. 76-2410(UNKNOWN) QTY: 43. 73-2414(UNKNOWN) QTY: 2. 76-2602(UNKNOWN) QTY: 8. 73-2632(UNKNOWN) QTY: 2. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL PROCEDURE. SUBSEQUENTLY, THE PATIENT HAD A CT SCAN CONDUCTED WHICH REVEALED 3 OF THE PLATES WERE FRACTURED ON THE SAME SIDE. THE PATIENT WAS NOT EXPERIENCING ANY PAIN. FURTHER, THE SURGEON NOTED THE PLATE FRACTURE WAS DUE TO THE SURGEON FIXING THE RIBS TO CARTILAGE INITIALLY VERSUS FIXING RIB TO RIB. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998712 UNKNOWN PLATE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown