BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS EXTRACTION BOLT

    MDR report key: 6064365 · Received October 28, 2016

    Report

    Report Number
    9681851-2016-00031
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 30, 2016
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE EXTRACTION BOLT FRACTURED AT THE BEGINNING OF THE THREAD. FRACTURED SURFACE SHOWS A TORSION FRACTURE. PROBABLY TO MUCH FORCE WAS APPLIED. NO MANUFACTURING OR PRODUCTION ERROR WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DENTAL ABUTMENT SCREW HAD FRACTURED THE IMPLANT WAS ATTEMPTED TO BE RESCUED BY USING AN EXTRACTION BOLT. DURING THIS RESCUE ATTEMPT THE EXTRACTION BOLT HAD FRACTURED. IN CONSEQUENCE THE IMPLANT IS NOT RESTORABLE ANY LONGER. IT WILL BE REMOVED OR LEFT UNUSED IN THE PATIENTS JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714572 ANKYLOS EXTRACTION BOLT ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IMPLANTS MANUFACTURING GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention