BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 7803122 · Received August 21, 2018

    Report

    Report Number
    0002023141-2018-00759
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Report Date
    December 18, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTION HAS BEEN CORRECTED: DEVICE CODE THAT WAS REPORTED IN ADVERSE EVENT PROBLEM OF THE INITIAL REPORT HAS BEEN CORRECTED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). BRAND NAME UNKNOWN / NOT PROVIDED. DEVICE INFORMATION UNKNOWN / NOT PROVIDED. IMPLANT REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT HAS BEEN MADE TO OBTAIN THE BRAND NAME OF THE DEVICE. HOWEVER, EFFORTS TO OBTAIN SAID INFORMATION HAS BEEN UNSUCCESSFUL. THERE WERE FOUR FOLLOW UP ATTEMPTS TO OBTAIN IMPLANT INFORMATION BUT THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY INFORMATION REGARDING THE IMPLANT. THE CUSTOMER ALSO STATED THAT HE DID NOT KNOW WHAT SCREW WAS USED WITH THE IMPLANT. A PRELIMINARY INVESTIGATION TO IDENTIFY THE DEVICE WAS UNABLE TO BE PERFORMED DUE TO THE IMPLANT STILL BEING IMPLANTED IN THE PATIENT'S MOUTH. THE PRODUCT CODE WAS ABLE TO BE IDENTIFIED AS DZE AS ALL ZIMMER BIOMET IMPLANTS HAVE THE DZE PRODUCT CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL THREADS OF THE UNKNOWN ZIMMER IMPLANT WERE DAMAGED. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY INFORMATION REGARDING THE IMPLANT AND, THEREFORE, THE IMPLANT INFORMATION IS UNKNOWN. THE DOCTOR REQUESTED A THREAD TAP TO RETHREAD THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641328 DENTAL IMPLANT DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1