BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ATIS ABUTMENT

    MDR report key: 15672507 · Received October 26, 2022

    Report

    Report Number
    3013111692-2022-22148
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 2, 2022
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS IN RESPONSE TO A COMMUNICATION RECEIVED FROM FDA FOR THIS COMPLAINT. THIS IS TO CORRECT INFORMATION ON THE REPORT OR WAS MISSING ACCORDING TO THE COMMUNICATION RECEIVED. THE PRODUCT CODE IS BEING CORRECTED FROM DEZ (COMMON DEVICE NAME: IGM, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL) TO DZE (COMMON DEVICE NAME: IMPLANT, ENDOSSEOUS, ROOT-FORM). THE UNIQUE IDENTIFIER (UDI)# IS BEING CORRECTED TO UNKNOWN. -THE EXACT ARTICLE WHICH CAUSED THE EVENT IS UNKNOWN, SINCE IT WAS NOT GIVEN BY THE DOCTOR. THE CASE IS ABOUT A FRACTURED HEALING ABUTMENT BUT ONLY THE IMPLANT WHICH WAS REMOVED WAS RETURNED, JUST WITH THE THREAD FRAGMENT OF THE HEALING ABUTMENT INSIDE. SO IT IS NOT IDENTIFIABLE AND WILL REMAIN AS UNKNOWN. THE CONCOMITANT MEDICAL PRODUCTS IS BEING CORRECTED FROM 24933, LOT: 486119 TO OSSEO SPEED TX 3.5 S - 13MM CATALOG # 24933 LOT # 24933 UDI # (B)(4). - THIS IS INCLUDING THE REQUESTED UDI # FOR THE IMPLANT.

    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
    2573201 UNKNOWN ATIS ABUTMENT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNKNOWN
    2797606 UNKNOWN ATIS ABUTMENT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention 24933, LOT: 486119| OSSEOSPEED TX 3.5S-13MM UDI #(B)(4)