BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® LARGE HEXED SCREW

    MDR report key: 8467011 · Received March 29, 2019

    Report

    Report Number
    0001038806-2019-00253
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Report Date
    July 24, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. 0001038806 - 2019 - 00255 - 1 HAS ALSO BEEN SUBMITTED. THE FOLLOWING SECTIONS ARE BEING REPORTED: B5: IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED. THERE WAS NO REPORT OF PATIENT INJURY. D10: CORRECTION: 01 MAR 2019, G4: 22 JUL 2019, G7: FOLLOW UP, H1: MALFUNCTION, H2: ADDITIONAL INFORMATION, H3: YES, EVALUATION SUMMARY ATTACHED AND H6: METHOD, RESULTS, CONCLUSION. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THAT THERE WAS NO EVIDENCE OF FRACTURE. THE REPORTED CONDITION OF AN ABUTMENT SCREW THAT FRACTURED WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE REPORTED DEVICE LOT NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR THE REPORTED DEVICE ITEM NUMBER DATING BACK 12 MONTHS FOR SIMILAR EVENTS AND NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE SUBJECT ITEM RELATED TO THE REPORTED EVENT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED. THERE WAS NO REPORT OF PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL 510K: K072642. THE FOLLOWING INFORMATION IS UNKNOWN AT THE TIME OF THIS REPORT: PATIENT INFO: NOT PROVIDED. DATE OF EVENT: UNKNOWN. INITIAL REPORTER: FIRST/GIVEN NAME NOT PROVIDED. MANUFACTURE DATE: UNKNOWN. THE REPORTED DEVICE HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256538 CERTAIN® GOLD-TITE® LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1