BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5X6MM HT SD X-DR SCR 5-PK

    MDR report key: 25317436 · Received May 28, 2026

    Report

    Report Number
    0001032347-2026-00128
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 10, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBW
    PMA / PMN Number
    K121624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 069270. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 104100. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 136870. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 180920. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 259865. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 286740. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 299410. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 325070. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 346380. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 361320. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 372540. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 389350. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 728330. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 823860. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 851100. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 852170. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 874620. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - 926990. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J6640277. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J67048529. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J6706527. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J7820138. D4 - CATALOG NUMBER - 95-6106. D4 - LOT NUMBER - J7820140. G2: FOREIGN - EVENT OCCURRED IN SPAIN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; 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 DURING INITIAL IMPLANTATION, TWO SCREWS FRACTURED WHILE THE SURGEON WAS ADJUSTING THEM TO THE PATIENT. THE PROCEDURE WAS SLIGHTLY DELAYED, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY BY IMPLANTING ANOTHER SCREW. THERE WAS NO REPORTED PATIENT HARM OR INJURY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545904 1.5X6MM HT SD X-DR SCR 5-PK FASTENER, PLATE, CRANIOPLASTY HBW BIOMET MICROFIXATION SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1