BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM

    MDR report key: 8700771 · Received June 14, 2019

    Report

    Report Number
    0002023141-2019-00277
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 15, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TAPERED SCREW-VENT IMPLANT (TSV6B10) WAS RETURNED WITH AN ATTACHED CROWN FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED IMPLANT IDENTIFIED BONE RESIDUE BUT NO SIGN OF DAMAGE WITHIN THE EXTERNAL THREADS OF THE IMPLANT. THE COLLAR AND INTERNAL HEX OF THE IMPLANT WERE UNABLE TO BE INSPECTED DUE TO THE ATTACHED CROWN (IMAGE 1). AS A CONSEQUENCE, ACCURATE MEASUREMENT ANALYSIS COULD NOT BE CONDUCTED. THE IMPLANT SYSTEM WAS LOCATED AT DENTAL POSITION #30 AND WAS IMPLANTED FOR APPROXIMATELY 5 YEARS. THE PATIENT WAS ALSO REPORTED TO HAVE UNKNOWN BONE DENSITY. NO OTHER PRE-EXISTING PATIENT CONDITIONS WERE NOTED ON THE PER OR IN THE COMPLAINT FORM. NO X-RAY IMAGES WERE PROVIDED FOR THE REPORTED EVENTS. DHR REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THAT PRODUCTS ARE WITHIN SPECIFICATIONS. STERILIZATION RECORD REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE IMPLANT (TSV6B10) DATING BACK TO 12 MONTHS PRIOR TO THE NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENTS. JULY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION/BONE LOSS) OR FOR THE REPORTED DEVICE (TSV6B10). BASED ON THE INVESTIGATION, MALFUNCTION OF THE IMPLANT COULD NOT BE VERIFIED AS MEASUREMENT ANALYSIS COULD NOT BE CONDUCTED AND NO LOT NUMBER WAS AVAILABLE TO CONDUCT DHR/STERILIZATION REVIEW. THE REPORTED EVENTS (INFECTION, BONE LOSS) ARE NON-VERIFIABLE AS THEY ARE MEDICAL CONDITION EVENTS AND NO X-RAYS WERE PROVIDED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT, 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 COMPLAINT (B)(4). PATIENT'S WEIGHT UNKNOWN/ NOT PROVIDED. DEVICE LOT NUMBER UNKNOWN/ NOT PROVIDED. ADDITIONAL 510(K) NUMBER K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT (TSV6B10) WAS REMOVED DUE TO PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495344 IMPL TAPERED SCR-V SBM 6M M 5.7MM 10MM IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention