BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIX ANKER LONG POST 1

    MDR report key: 25300717 · Received May 27, 2026

    Report

    Report Number
    8031010-2026-00062
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. INVESTIGATION RESULTS: RADIX ANKER LONG POST 1 LOT#1927624 DENTSPLY SIRONA BENSHEIM REPORTED THAT "THE RADIX ANCHOR WAS PLACED, AND AFTER A WHILE THE PATIENT RETURNED BECAUSE THE ANCHOR HAD FRACTURED INSIDE THE CANAL. THE CANAL HAD BEEN PREPARED BEFOREHAND WITH A SHAPING BUR, WHICH BROKE OFF DURING USE; IT DID NOT REMAIN IN THE CANAL". THE BATCH NUMBER IS KNOWN, CERTIFICATE OF CONFORMITY IS AVAILABLE. NO RELEVANT INFORMATION WAS FOUND DURING DHR REVIEW (NO NONCONFORMING MATERIAL REPORT WAS ISSUED DURING MANUFACTURING OR PACKAGING PROCESSES). FOR INFORMATION, THIS IS THE FIRST COMPLAINT RECEIVED INVOLVING THIS BATCH NUMBER FOR THIS ISSUE. PLEASE NOTE THAT THIS PRODUCTION WAS MADE UNDER THE PROCESS DEVIATION (B)(4), ISSUED TO ADD A CONTROL OF THE RUNOUT ON SOME RAW MATERIAL BARS WHICH MIGHT HAVE BEEN DAMAGED DURING TRANSPORT. NO RELATION WITH THE SUBJECT OF THE COMPLAINT.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A RADIX ANKER LONG POST 1 WAS PLACED INSIDE THE CANAL, THE PATIENT RETURNED DUE TO THE ANCHOR FRACTURING. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344024 RADIX ANKER LONG POST 1 POST, ROOT CANAL ELR MAILLEFER INSTRUMENTS HOLDING SARL 1927624

    Patients

    Seq Age Sex Outcome Treatment
    1