BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX BLU SCR S/D-LK 2.4X10MM

    MDR report key: 21687963 · Received March 25, 2025

    Report

    Report Number
    0001032347-2025-00137
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 27, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K142823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, A4, B4, B5, D6, G3, G6, H2, H3, H6, H11. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS: ITEM# 85-2410, LOT# NI, 2.4MMX10MM HT X-DR SCREW 5PK. ITEM# 24-1060, LOT# NI, 16 HOLE QTY 1 ITEM #76-2601, LOT# NI; RIBFIX BLU 8 HOLE STRAIGHT PLT. G2: FOREIGN SOURCE: GERMANY. 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

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT FELL FROM A TREE AND RIB FRACTURES WERE NOT IMMEDIATELY DIAGNOSED. PATIENT WAS ADMITTED TO THE HOSPITAL AFTER COMPLAINING OF PAIN IN THE THORAX WHILE SLEEPING. THE SUGGESTED TREATMENT PLAN WAS TO PLATE 3 RIBS. HOWEVER, ABOUT THREE MONTHS LATER THE PATIENT PRESENTED WITH PAIN. A CT SCAN SHOWED ONE PLATE WAS FRACTURED AND ONE PLATE HAD A SCREW THAT BACKED OUT AND WAS NO LONGER ANCHORED IN THE PLATE. THE PATIENT WAS REVISED WITH PLATES AND SCREWS IN THE SITUS BEING REMOVED. THE PHYSICIANS HAVE THE IMPRESSION THAT THE RIBS HAD GROWN TOGETHER WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093538 RIBFIX BLU SCR S/D-LK 2.4X10MM SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10.