BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 11.5 MM

    MDR report key: 10808375 · Received November 9, 2020

    Report

    Report Number
    0001038806-2020-01785
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    January 29, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868022213
    PMA / PMN Number
    K130949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT (XIITP6511) AND ASSOCIATED ENCODE HEALING ABUTMENT WERE RETURNED FOR INVESTIGATION. THE REPORTED EVENT OCCURRED AT IMPLANT LEVEL; THEREFORE, THIS INVESTIGATION WAS PERFORMED ONLY ON THE RETURNED IMPLANT. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED SIGNS OF WEAR AND BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE/EVENT (NERVE INJURY). HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPER (ID: CAL002C159; DUE DATE: 11-JUN-2021). FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS (DWG NO. 850007 REV C), THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS (IMAGE 3). PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY ¿ TYPE III. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH # 30 (UNKNOWN NOTATION SYSTEM) FOR ONLY 1 DAY. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (2019030506) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AFTER IMPLANTATION OF THE DEVICE. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (2019030506) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT ANATOMICAL CONDITIONS WERE UNKNOWN/NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP". H3: CHANGED "NO" TO "YES".

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO NERVE INJURY. IMPLANT WAS PLACED AND THE PATIENT WAS FINE THE DAY OF SURGERY. X-RAY AND EVERYTHING WAS NON SYMPTOMATIC. PATIENT REPORTED NUMBNESS AND PAIN THE NEXT DAY. IMPLANT WAS REMOVED. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, BONE GRAFTED. ADDITIONAL APPOINTMENT REQUIRED: YES, 4-5 MONTHS TO REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & PARESTHESIA, NUMBNESS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274681 OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 11.5 MM DENTAL IMPLANT DZE BIOMET 3I XIITP6511 2019030506 00844868022213

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention