BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 11.5MM

    MDR report key: 8776409 · Received July 10, 2019

    Report

    Report Number
    0001038806-2019-00666
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    May 29, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K130949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 11.5MM (XIITP4311) WAS RETURNED FOR INVESTIGATION WITH A MATING COVER SCREW. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED A LARGE AMOUNT OF DRIED BLOOD SURROUNDING THE THREADS AND DRIVE FEATURE. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 850005 REV C (DIGITAL CALIPER; CAL 3736; OCT 23, 2019). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 30 AND USED FOR APPROXIMATELY 2 YEARS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: 2012041792. 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 (OP0210) 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: (2012041792) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (BONE LOSS + INFECTION) OR PRODUCT: (XIITP4311). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE. INFECTION, INFLAMMATION AND BONE LOSS ARE LISTED AS A HARM OR POTENTIAL EFFECT OF IMPLANT FAILURE. THEREFORE, THE PROBABLE CAUSE(S) FOR IMPLANT FAILURES THAT COULD POSSIBLY LEAD TO INFECTION AND BONE LOSS WERE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. 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 COMPLAINT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANT (XIITP4311) WAS EXTRACTED DUE TO PERIIMPLANTITIS. TOOTH LOCATION 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569584 OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2012041792

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention