BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM

    MDR report key: 15232591 · Received August 16, 2022

    Report

    Report Number
    3013111692-2022-16338
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    May 20, 2022
    Report Date
    October 7, 2022
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    NHA
    PMA / PMN Number
    K053384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    CORRECTING THE CONCOMITANT MEDICAL PRODUCTS 24485 TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM THAT WAS INITIALLY REPORTED IN THE INITIAL (1ST) REPORT TO CONCOMITANT MEDICAL PRODUCTS 24940 OSSEOSPEED TX 4.0S - 8 MM. THIS IS A FOLLOW UP REPORT TO CORRECT THE CONCOMITANT MEDICAL PRODUCTS INFORMATION.

    Additional Manufacturer Narrative · 0

    DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM OSSEOSPEED TX 4.0S - 8 MM CATALOG # 24940 TO TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM CATALOG # 24285. PRODUCT CODE IS BEING CORRECTED FROM DZE TO NHA. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: COMPONENT CODE - 887. THE CORRECT CODES FOR THIS COMPLAINT ARE: COMPONENT CODE - 568.

    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
    1221885 TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IMPLANTS MANUFACTURING GMBH UNK
    2258525 TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 24485 TIDESIGN 3.5/4.0 - Ø 4.5,1.5MM| 24940 OSSEOSPEED TX 4.0S - 8 MM.