BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

    MDR report key: 9954200 · Received April 13, 2020

    Report

    Report Number
    0002023141-2020-00756
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    January 17, 2020
    Report Date
    June 3, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR COMPLAINTS FOR BONE LOSS RELATED PROBLEMS HAVE BEEN PREVIOUSLY INVESTIGATED. REFER TO ATTACHED SUMMARY INVESTIGATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PREVIOUSLY RETURNED PRODUCT HAVE NOT IDENTIFIED OR SUGGESTED MANUFACTURING NON-CONFORMANCES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS ESCAPING THE AVAILABLE DETECTIONS IS REMOTE AND ALMOST NONEXISTENT. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. ADDITIONALLY, ALL DEVICE HISTORY RECORD REVIEWS VERIFIED THAT EACH IMPLANT WAS STERILIZED PER PROCEDURE FOR EVERY DEVICE. ALL COMPLAINT DATA USED FOR THE SUMMARY INVESTIGATION WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/IE ESCALATION. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DHR WAS NOT AVAILABLE ELECTRONICALLY FOR THE SUBJECT LOT NUMBER (1221088) THUS COULD NOT BE FURTHER REVIEWED AT THE TIME OF THE INVESTIGATION. A NOTIFICATION/REQUEST HAS BEEN SENT TO MANUFACTURING TO PULL THE DHR FOR REVIEW. THE PCE WILL BE REOPENED AND UPDATED IF THERE IS ANY INDICATION OF NONCONFORMANCE, OR ANY POSSIBLE MANUFACTURING ISSUE RELATED TO THE REPORTED EVENT. SINCE THE DHR WAS NOT AVAILABLE, A SEARCH IN TIPQA WAS CONDUCTED WITH THE LOT NUMBER TO DISCOVER ANY NON-CONFORMANCES RELATED TO THE REPORTED EVENT AND SUBJECT LOT NUMBER. NO NON-CONFORMANCES WERE FOUND FOR THE SUBJECT LOT NUMBER. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1221088) FOR A SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET CONTROL, INCLUDING THOSE RELATED TO MEDICAL CONDITIONS / PATIENT HABITS AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION AND NO ASSOCIATION BETWEEN THE DENTAL IMPLANT AND BONE LOSS WAS FOUND THAT CAN EXPLAIN THESE EVENTS. THEREFORE, THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT (TSVWH10) WAS REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 19. SITE WAS BONE GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416556 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1221088

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention