BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 3.5S - 11 MM

    MDR report key: 16823627 · Received April 27, 2023

    Report

    Report Number
    3013111692-2023-41027
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    March 7, 2023
    Report Date
    June 21, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532108372
    PMA / PMN Number
    K101005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDING UDI # (B)(4). 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 TIDESIGN 3.5/4.0 - Ø 4.5, 3MM CATALOG # 24286 TO OSSEOSPEED TX 3.5S - 11 MM CATALOG # 24932. CORRECTING PRODUCT CODE FROM NHA TO DZE; THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE. CORRECTING CONCOMITANT PRODUCT FROM 24932 TO 24286; THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - IMPACT CODE - 4627. MEDICAL DEVICE PROBLEM CODE - 1260. COMPONENT CODE - 887. INVESTIGATION FINDINGS CODE - 3252 + 3243. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - IMPACT CODE - 4621. MEDICAL DEVICE PROBLEM CODE - 2408. INVESTIGATION FINDINGS CODE - 213.

    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 AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. PRODUCT RETURN IS REQUESTED AND PRODUCT 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013923 OSSEOSPEED TX 3.5S - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 24932 UNK 07392532108372
    1590838 OSSEOSPEED TX 3.5S - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 24932 UNK 07392532108372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 24286| 24932