BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBODY DUAL ANCHOR INSERTER, BIOABSORBABLE ANCHORS

    MDR report key: 23265279 · Received October 10, 2025

    Report

    Report Number
    3015543569-2025-00003
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 19, 2025
    Report Date
    January 28, 2026
    Manufacturer
    EMBODY, INC
    Product Code
    MAI
    PMA / PMN Number
    K213958
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; D9; G1; G3; G6; H1; H2; H3; H4; H6. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS AND RETURNED PRODUCT IDENTIFIED THAT THE FOIL PACKAGING HAS TWO PUNCTURE HOLES, AND THE TYVEK HAS PUNCTURE HOLES. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO MANUFACTURING. COMPLAINT WAS CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGE WAS NOTED TO HAVE THE NEEDLES EXTENDING IN IT, PUNCTURING THE PACKAGE. NO PATIENT WAS INVOLVED IN THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312050 EMBODY DUAL ANCHOR INSERTER, BIOABSORBABLE ANCHORS FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI EMBODY, INC NI 062551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown