BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTO SCR 2.0X7MM 2.0 SYS 2/PK

    MDR report key: 13401673 · Received January 31, 2022

    Report

    Report Number
    0001032347-2022-00040
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    December 27, 2021
    Report Date
    April 21, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00888233025232
    PMA / PMN Number
    K002083
    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# 915-2151, LOT# 832450, 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED. 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: 0001032347-2022-00003, 0001032347-2021-00002.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B4, B5, D4, G3, G6, H2, H4 AND H10.

    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.

    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
    1640525 LACTO SCR 2.0X7MM 2.0 SYS 2/PK PLATE, BONE JEY BIOMET MICROFIXATION N/A 589700 00888233025232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10