BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOREIGN ARTICLE APG010

    MDR report key: 21126702 · Received January 10, 2025

    Report

    Report Number
    9610612-2025-00005
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    January 2, 2025
    Report Date
    April 3, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    EMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTION: B5 - DESCRIPTION UPDATED D SECTION - PRODUCT UPDATED, DEVICE RECEIVED DATE ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3,, THIS EVENT IS CONSIDERED NO LONGER REPORTABLE FOR THE FOLLOWING REASONS: - NO SERIOUS PUBLIC HEALTH THREAT / FALSIFIED DEVICE - NO SERIOUS INCIDENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    UPDATE: ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE COMPLAINED PRODUCT WAS NON-AESCULAP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DO655R HEMINGWAY SHARP SPOON DBL.END.170MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CURRETTE FRACTURED DURING A DENTAL PROCEDURE AND ALVEOLAR CURETTAGE. AN X-RAY WAS TAKEN AS WELL AS A SEARCH OF THE BACK TABLE AND SURGICAL SITE, AND THE FRAGMENT WAS RETRIEVED. THIS CAUSED AN UNSPECIFIED SURGICAL DELAY. A PICTURE CONFIRMED THE FRACTURE. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462251 FOREIGN ARTICLE APG010 DENTAL EMK AESCULAP AG FREMD010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention