BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTO SCR 1.5X4MM 1.5 SYS 2PK

    MDR report key: 23223417 · Received October 6, 2025

    Report

    Report Number
    0001032347-2025-00404
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 5, 2025
    Report Date
    February 17, 2026
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K955729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    (B)(4). D6: UNKNOWN DATE IN (B)(6) 2025. D10: LACTO 1.5 2X2 SQUARE PLATE CAT#915-2426 LOT#280480. LACTO 1.5 2X2 SQUARE PLATE CAT#915-2426 LOT#65988363. LACTO 1.5 2X2 SQUARE PLATE CAT#915-2426 LOT#65988363. LACTO SCR 1.5X4MM 1.5 SYS 2PK CAT# 915-2315 LOT# 66204803. LACTO SCR 1.5X4MM 1.5 SYS 2PK CAT# 915-2315 LOT# 66303545. LACTO SCR 1.5X4MM 1.5 SYS 2PK CAT# 915-2315 LOT# 66307891. LACTO SCR 1.5X4MM 1.5 SYS 1PK CAT# 915-2315-EA LOT# 66619072. LACTO SCR 1.5X4MM 1.5 SYS 1PK CAT# 915-2315-EA LOT# 66619072. G2: JAPAN. 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

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO A PROTRUDING AND MIGRATED LACTOSORB PRODUCT THAT WAS CAUSING SWELLING AND REDNESS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574848 LACTO SCR 1.5X4MM 1.5 SYS 2PK CRANIOFACIAL BONE SCREW, BIOABSORBABLE HRS BIOMET MICROFIXATION NI 66239019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.