BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 4.0S - 9 MM

    MDR report key: 17037488 · Received June 1, 2023

    Report

    Report Number
    1222802-2023-00009
    Event Type
    Injury
    Date Received
    June 1, 2023
    Report Date
    June 12, 2023
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    DZE
    PMA / PMN Number
    MULTIPLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING INVESTIGATION FINDINGS CODE 213. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING TYPE OF INVESTIGATION CODE 10. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM S ATLANTIS ABUTMENT TI CATALOG # 35502 TO OSSEOSPEED TX 4.0S - 9 MM CATALOG # 24941. PRODUCT CODE IS BEING CORRECTED FROM NHA TO DZE. CORRECTED CONCOMITANT TO S ATLANTIS ABUTMENT TI CAT# 35502. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: MEDICAL DEVICE PROBLEM CODE - 1260. COMPONENT CODE - 887. THE PHYSICAL INVESTIGATION OF THE RETURNED ITEMS REVEALED THAT NO FRACTURE HAD OCCURRED. THE CORRECT CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 2408.

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. A FRACTURED ABUTMENT HAD LED TO THE IMPLANT REMOVAL. COMPLAINED ABUTMENT WAS NOT RECEIVED. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296279 OSSEOSPEED TX 4.0S - 9 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IH INC.
    1972730 OSSEOSPEED TX 4.0S - 9 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention IMPLANT FAILED AS A RESULT OF THE THE SCREW FRACTU| S ATLANTIS ABUTMENT TI CAT# 35502