BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 10015651 · Received April 30, 2020

    Report

    Report Number
    0002023141-2020-00822
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    February 27, 2019
    Report Date
    July 15, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM TSVH11 WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS-RETURNED PRODUCT IDENTIFIED SIGNS OF BONE RESIDUE AROUND THE EXTERNAL THREADS. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURES (INABILITY TO PLACE AND BONE FRACTURE). MEASUREMENTS WERE TAKEN USING A CALIPER. THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, IT WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS. PRE-EXISTING CONDITIONS WERE NOTED ON THE PER WAS HIGH BONE DENSITY TYPE I. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 20 (UNIVERSAL) WHEN THE INCIDENT OCCURRED. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1221395). 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1221395) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR PRODUCT. THEREFORE, 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 / NONVERIFIABLE. BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS PLACEMENT OF IMPLANT IN A PATIENT WITH PATIENT FACTORS (E.G. POOR HYGIENE, PERIODONTAL ISSUES, PRE-EXISTING MEDICAL CONDITIONS) OR CLINICIAN FAILURE TO FOLLOW RECOMMENDED PROTOCOL FOR IMPLANT PLACEMENT / SEATING. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G5: ADDITIONAL PMA/510(K) NUMBER: K013227. 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 COMPLAINT (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT (TSVH11) PLACEMENT A BONE DEHISCENCE / FRACTURE OCCURRED AND IMPLANT DID NOT GET PRIMARY STABILITY AND IT WAS REMOVED. SITE WAS BONE GRAFTED AND PATIENT WILL WAIT 3 MONTHS FOR FUTURE PLACEMENT. TOOTH LOCATION 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479848 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1221395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention