BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H)

    MDR report key: 15221619 · Received August 12, 2022

    Report

    Report Number
    0001038806-2022-01261
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Report Date
    January 31, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868009269
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET 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 UPDATED: 3331, 4109, 4110, 4111, 4114. H6: INVESTIGATION FINDINGS CODE WAS UPDATED: 213. H6: INVESTIGATION CONCLUSION CODE WAS UPDATED: 4315. H10: NARRATIVE/DATA WAS UPDATED. ONE CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H) (IWTH573) WAS REPORTED BUT NOT RETURNED FOR INVESTIGATION. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED FOR THE ABUTMENT. THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICES. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMVIE. DHR REVIEW FOR THE LOT (1240286) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCE'S WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS NUMBER (1240286) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION IMPROPER TECHNIQUES USED OR FAILURE TO FOLLOW RECOMMENDED PROTOCOL FOR IMPLANT PLACEMENT. 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 PATIENT WAS MISSING A HEALING ABUTMENT DURING A IMPLANT STABILITY TEST. IT IS UNKNOWN WHEN IT BECAME MISSING.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110483 CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H) DENTAL ABUTMENT NHA BIOMET 3I IWTH573 1240286 00844868009269

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown