BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® GOLD-TITE® LARGE HEXED SCREW

    MDR report key: 8466983 · Received March 29, 2019

    Report

    Report Number
    0001038806-2019-00254
    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 INFORMATION. 0001038806-2019-00255-1 , 0001038806-2019-00253-1, 0001038806-2019-00256-1 AND 0001038806-2019-00252-2 HAVE ALSO BEEN SUBMITTED. THE FOLLOWING SECTIONS ARE BEING REPORTED: G4: 22 JUL 2019, G7: FOLLOW UP , H1: MALFUNCTION, H2: ADDITIONAL INFORMATION, H3: YES, EVALUATION SUMMARY ATTACHED, H6: METHOD, RESULTS, CONCLUSION AND H10: MANUFACTURER NARRATIVE. 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

    NO NEW EVENT INFORMATION TO REPORT AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT IDENTIFIER UNKNOWN/ NOT PROVIDED. PATIENT'S AGE UNKNOWN/ NOT PROVIDED. PATIENT'S WEIGHT UNKNOWN/ NOT PROVIDED. EVENT DATE UNKNOWN. REPORTER'S EMAIL ADDRESS UNKNOWN. ADDITIONAL 510(K) NUMBER K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT SCREW (ILRGHG) FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257208 CERTAIN® GOLD-TITE® LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1