BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED

    MDR report key: 13402015 · Received January 31, 2022

    Report

    Report Number
    0001032347-2022-00003
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    December 27, 2021
    Report Date
    April 21, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036054670
    PMA / PMN Number
    K992355
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCTS : ITEM# 915-2301, LOT# 894960, 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW; ITEM #915-2301, LOT# 589700, 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00002, 0001032347-2022-00040.

    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. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE UNDER LOCAL ANESTHESIA APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO DRAINAGE AND PLATE EXPOSURE FROM THE ORAL VESTIBULE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683914 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 832450 00841036054670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10