BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMETAPER DRILL SLEEVE 4ND GS

    MDR report key: 24784378 · Received April 4, 2026

    Report

    Report Number
    3013111692-2026-10982
    Event Type
    Malfunction
    Date Received
    April 4, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 3, 2026
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532269950
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. PRODUCTS RETURN IS REQUESTED AND WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED LOSS OF INTERNAL SPRING WITHIN THE DRILL SLEEVE. 2026-03-12 DIOGP514: SPRING RING ISSUE ¿ CAPA NUMBER 2025-58. EVENT DEEMED NOT REPORTABLE IN COUNTRIES OTHER THAT THE US AS FOLLOW: EU: IT DOES NOT MEET THE CRITERIA OF A SERIOUS INCIDENT AND REFLECTS A DOCUMENTED INHERENT DEVICE RISK, THE EVENT IS DEEMED NOT REPORTABLE TO THE CA, BUT WILL BE DOCUMENTED AND MONITORED THROUGH POST-MARKET SURVEILLANCE. BR: NOT MARKETED/ RELEASED. AU: THE EVENT OCCURRED OVERSEAS. CA: EVENT OCCURRED IN A FOREIGN COUNTRY WITH A CLASS II DEVICE. CN: THE EVENT DID NOT CAUSE A DEATH, NOR SEVERE INJURIES OR COULD HAVE POSSIBLY CAUSED SEVERE INJURIES/DEATH AND NO SERIOUS PUBLIC HEALTH THREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565792 PRIMETAPER DRILL SLEEVE 4ND GS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 531963 07392532269950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NOT PROVIDED