BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUT GOLD FRICTION-FIT 4. 5MM IMP

    MDR report key: 8499779 · Received April 10, 2019

    Report

    Report Number
    0002023141-2019-00150
    Event Type
    Injury
    Date Received
    April 10, 2019
    Report Date
    July 5, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ABUT GOLD FRICTION-FIT 4. 5MM IMP (HLA4G) AND UNKNOWN ZIMMER IMPLANT WERE NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION. DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBERS ASSOCIATED WITH THE REPORTED PRODUCTS ARE NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (HLA4G) DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON CONFORMANCES/CAPA /HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE. APRIL POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (STUCK ABUTMENT) OR DEVICES (HLA4G). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENTS OF STUCK RESTORATIVE COMPONENTS AND DAMAGED IMPLANT THREADS WERE NON-VERIFIABLE WITHOUT RETURN OF THE PRODUCT FOR REVIEW. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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, 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). PMA/510(K) NUMBER: K013227, K953101. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ABUTMENT (HLA4G) COULD NOT RELEASE FROM THE IMPLANT. DOCTOR WAS ABLE TO REMOVE THE ABUTMENT AND IMPLANT WAS STRIPPED IN THE PROCESS. IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294479 ABUT GOLD FRICTION-FIT 4. 5MM IMP ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN DENTAL IMPLANT| UNKNOWN DENTAL IMPLANT