BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTO SORB SYSTEM 14MM RAPIDFLAP CLAMP

    MDR report key: 15977541 · Received December 14, 2022

    Report

    Report Number
    0001032347-2022-00385
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    October 15, 2021
    Report Date
    December 14, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053864
    PMA / PMN Number
    K003281
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). YEAR OF BIRTH 2014. CONCOMITANT MEDICAL PRODUCTS:¿ ITEM# 915-0020, LOT 205860 QTY 2. FOREIGN SOURCE: COLOMBIA. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2022-00384, 0001032347-2022-00387.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462960 LACTO SORB SYSTEM 14MM RAPIDFLAP CLAMP PLATE, BONE JEY BIOMET MICROFIXATION N/A 205860 00841036053864

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention| H