BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM

    MDR report key: 9948864 · Received April 10, 2020

    Report

    Report Number
    0001038806-2020-00672
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    February 19, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM (INT510) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SLIGHT BONE ON THREADS. ALSO A HEALING ABUTMENT. HOWEVER, NO DAMAGE OR MALFUNCTION WAS IDENTIFIED. THE RETURNED DEVICE WAS MEASURED WITH A CALIPER (CAL1334 CAL DUE: SEP 25, 2020) AND VERIFIED TO MATCH DHR SPECIFICATIONS PER DWG NO. 223244 REV V. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 14 AND WAS USED FOR APPROXIMATELY 1 YEAR 4 MONTHS. PICTURES OR X-RAY IMAGES OF THE IMPLANT SITE WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (2017100362). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (OP180) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (2017100362) FOR A SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS CUSTOMER ERROR WITH INADEQUATE TREATMENT PLANNING AND CLINICIAN INADVERTENTLY SELECTS A LENGTH OF IMPLANT THAT IS TOO LONG FOR THE OSTEOTOMY. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). INITIAL REPORTER EMAIL ADDRESS: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (INT510) LOSS ITS INTEGRATION RESULTING IN A SINUS COMMUNICATION. SURGICAL/MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT. DOCTOR COMPLETE THE PROCEDURE WITH A CLOSURE OF THE SINUS AREA WHERE THE IMPLANT WAS LOCATED. SITE WAS BONE GRAFTED. TOOTH LOCATION 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414248 OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I 2017100362

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention