BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X4MM HT SD X-DR SCR EA

    MDR report key: 22106216 · Received May 29, 2025

    Report

    Report Number
    0001032347-2025-00220
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBW
    UDI-DI
    00841036053734
    PMA / PMN Number
    K953385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: A2, B5, D10, E1, H2, H3, H4, H6 AND H11. D10 - CONCOMITANT MEDICAL PRODUCTS: ITEM #: 01-7104 ITEM NAME: 1.5 5 HOLE XLONG Y LOT #: J7698662 ITEM #: 01-7136 ITEM NAME: 1.5 2X3 HOLE RECTANGLE LOT #: 241750 ITEM #: 01-8664 ITEM NAME: PLATE RGD 1.5/0.6 4 HOLE LOT #: 722460 ITEM #: 91-6104 ITEM NAME: 1.5X4MM HT SD X-DR SCR EA LOT #: J66803168 QTY: 7 ITEM #: 01-9123 ITEM NAME: DEPTH GAGE 1.5/2.0 45MM LOT #: INT019123 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PRODUCT WAS NOT RETURNED AS IT WAS RETAINED BY THE PATIENT. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM # 91-6104, LOT # J67068443: 1.5X4MM HT SD X-DR SCR EA. G2: FOREIGN SOURCE: BRAZIL. 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 THAT THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE. DURING THE PROCEDURE, TWO SELF-DRILLING SCREWS FRACTURED AFTER BEING IMPLANTED IN THE CRANIAL REGION. THE FRACTURED DEVICES WERE RETAINED. DUE TO THE EVENT, THERE WAS A SMALL DELAY IN THE PROCEDURE. PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE PATIENT HAD CANCER AND UNDERWENT A CRANIOTOMY TO REMOVE A TUMOR. THE PATIENT SUFFERED A HEMATOMA THAT WAS NOT RELATED TO THE IMPLANTED PRODUCT AND THE SURGEON STATED THIS IS THE REASON THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT DURING A CRANIAL PROCEDURE, TWO SCREWS FRACTURED DURING THE PROCEDURE AFTER IMPLANTATION. THE SCREWS REMAIN IN THE PATIENT. PATIENT WILL BE MONITORED FOR ANY PROBLEMS THAT MIGHT BE CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596808 1.5X4MM HT SD X-DR SCR EA FASTENER, PLATE, CRANIOPLASTY HBW BIOMET MICROFIXATION J67068443 00841036053734

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other SEE H11.| SEE H11.