BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 LACTOSORB SYSTEM STRAIGHT PLATE - 8 HOLE

    MDR report key: 10771747 · Received November 2, 2020

    Report

    Report Number
    0001032347-2020-00541
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    March 25, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036055530
    PMA / PMN Number
    K955729
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A DHR REVIEW AND A REVIEW OF THE STERILE CERT CANNOT BE REVIEWED WITHOUT LOT INFORMATION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00540. MEDICAL PRODUCTS: 1.5 LACTOSORB SYSTEM CURVED PLATE - 6 HOLE, PART# 915-2427, LOT# NI. 1.5 LACTOSORB SYSTEM STRAIGHT PLATE - 8 HOLE, PART# 915-2417, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AND THE PLATE WAS REMOVED DUE TO BEING EXPOSED TWO (2) MONTHS FOLLOWING IMPLANTATION OF ABSORBABLE PLATES. THE SURGEON BROKE THE PLATE WITH A CHISEL AND REMOVED THE PLATE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233571 1.5 LACTOSORB SYSTEM STRAIGHT PLATE - 8 HOLE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A UNK 00841036055530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE