BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H)

    MDR report key: 17106764 · Received June 12, 2023

    Report

    Report Number
    0001038806-2023-01124
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    February 28, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868004615
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4315. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE DID NOT RECEIVE THE REPORTED HEALING ABUTMENT FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1240643. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1240643 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS MISSING OR CONFUSING INSTRUCTIONS FOR USE AND ABUTMENT SCREW IS NOT TORQUED TO SPECIFICATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION WAS NOT ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ENCODE SCREW IN THE IMPLANT AT TOOTH LOCATION #19 CAME LOOSE. THE SCREW WAS REPLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427704 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) DENTAL SCREW NHA BIOMET 3I IEHA446 1240643 00844868004615

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Prefer Not To Disclose