BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBODY DUAL ANCHOR INSERTER, BIOABSORBABLE ANCHORS

    MDR report key: 23425169 · Received October 30, 2025

    Report

    Report Number
    3015543569-2025-00004
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 9, 2025
    Report Date
    May 29, 2026
    Manufacturer
    EMBODY, INC
    Product Code
    MAI
    UDI-DI
    00810063820152
    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

    (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

    IT WAS REPORTED THAT WHILE PREPPING FOR SURGERY, THE CIRCULATING NURSE NOTED THE NEEDLES EXTENDING IN THE PACKAGING, CAUSING A PUNCTURE IN THE PACKAGE. THIS WAS NOTED OUTSIDE OF THE STERILE FIELD, SO 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
    2408544 EMBODY DUAL ANCHOR INSERTER, BIOABSORBABLE ANCHORS FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI EMBODY, INC NI 052580 00810063820152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown