BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 3MM(H)

    MDR report key: 18125919 · Received November 13, 2023

    Report

    Report Number
    0001038806-2023-02183
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 2, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K212730
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). A4: PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. D1: BRAND NAME IS NOT PROVIDED / UNKNOWN. D4: CATALOG NUMBER AND LOT NUMBER ARE NOT PROVIDED / UNKNOWN. D10: TSX47B11, TSX¿ IMPLANT, 4.7MMD, 11.5MML, LOT NUMBER UNKNOWN. E1: INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT CORRECTED INFORMATION TO 0001038806-2023-02183-1. FURTHER REVIEW OF THE EVENT, HAS CONFIRMED THAT THIS EVENT DOES NOT MEET THE REQUIREMENTS OF A REPORTABLE EVENT. FURTHER REVIEW OF THIS EVENT HAS REVEALED THAT THE MALFUNCTION OF THE ENCODE ABUTMENT DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE FAILED IMPLANT. THE MOST LIKELY CAUSE FOR THE IMPLANT COMING OUT, WAS THAT IT WAS NOT OSSEO INTEGRATED. THERE WILL BE NO FURTHER MEDWATCHES SUBMITTED FOR THIS EVENT. THE FOLLOWING SECTIONS ARE BEING REPORTED: B5. DESCRIBE EVENT OR PROBLEM, H2: IF FOLLOW-UP, WHAT TYPE, H10: ADDITIONAL NARRATIVES/DATA.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL AND CORRECTED INFORMATION TO 0001038806-2023-02183. FOLLOW UP WITH CUSTOMER CONFIRMED THE ITEM AND LOT NUMBER OF THE REPORTED ITEM. THE PRODUCT CODE HAS BEEN CORRECTED. THE FOLLOWING SECTIONS ARE BEING REPORTED: D1. BRAND NAME. D2 PRODUCT CODE CORRECTED. D4: CATALOG NUMBER AND LOT NUMBER. G4. PMA/510(K) #. H2: IF FOLLOW-UP, WHAT TYPE. H10: ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT CAME OUT DURING RESTORATION PROCESS. ENCODE ATTACHED TO IMPLANT. ENCODE IS STRIPPED. SITE GRAFTED: ALLOGRAFT, XENOGRAFT ON (B)(6) 2022.

    Description of Event or Problem · 0

    FURTHER REVIEW OF THIS EVENT HAS REVEALED THAT THE MALFUNCTION OF THE ENCODE ABUTMENT DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE FAILED IMPLANT. THE MOST LIKELY CAUSE FOR THE IMPLANT COMING OUT, WAS THAT IT WAS NOT OSSEO INTEGRATED.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203213 TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 3MM(H) DENTAL HEALING ABUTMENT NHA BIOMET 3I 1261563
    694887 TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 3MM(H) DENTAL HEALING ABUTMENT NHA BIOMET 3I 1261563

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention DENTAL IMPLANT, SEE H10 NARRATIVE.