BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED

    MDR report key: 9853312 · Received March 19, 2020

    Report

    Report Number
    0001032347-2020-00170
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    February 18, 2020
    Report Date
    August 28, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THERE IS A REPORTED REVISION SURGERY THE COMPLAINT IS CONSIDERED CONFIRMED. FUNCTIONAL TESTING COULD NOT BE CONDUCTED AS THE PRODUCTS WERE NOT RETURNED. PER CUSTOMER PROVIDED FOLLOW UP IT IS UNKNOWN IF THE INFECTION IS RELATED TO THE DEVICE OR WHAT THE CAUSE OF THE INFECTION IS. THE DHR AND STERILIZATION CERTIFICATES WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (915-2151) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING A REVISION SURGERY DUE TO INFECTION, THERE IS A COMPLAINT RATE OF 0.49% WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THE FAILURE MODE THAT LED TO THE INFECTION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (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: 0001032347-2020-00168, 0001032347-2020-00169. CONCOMITANT MEDICAL PRODUCTS: 1.5 LACTOSORB SYSTEM STRAIGHT PLATE - 4 HOLE, PART# 915-2413, LOT# 846820; 2.0 LACTOSORB SYSTEM STRAIGHT PLATE - EXTENDED - 4 HOLE, PART# 915-2111, LOT# 144990; 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED, PART# 915-2151, LOT# 957040. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE - (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE (3) BIO-ABSORBABLE PLATES WERE REMOVED DUE TO INFECTION APPROXIMATELY TWO (2) WEEKS FOLLOWING IMPLANTATION DURING A MIDFACE RECONSTRUCTION PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318439 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 957040 00841036054670

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R SEE H10 NARRATIVE.