MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	FNT3213
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Email address was not provided.
Event or Problem Description
The doctor reports that the mount cannot be removed from the implant.The doctor used another implant to complete the procedure.The doctor confirms that the patient did not suffer any type of problem or impact on his health and the affected dental position is 13.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One implant mount 3.4mm(d) x 3mm(l) (mmc03) and one full osseotite® tapered implant 3.25 x 13mm (fnt3213) were returned for investigation.Visual evaluation of the as returned implant identified signs of use and wear on the mount and implant.Dried blood present on the threads as well.Functional testing was performed and mount could not be disengaged from the implant.Hence, the reported event was recreated.Device history record (dhr) review was completed for the subject lot number (2018112227).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Complaint history review was completed for the subject lot number (2018112227) for does not disengage/release category through the manufacturers internal system and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: FULL OSSEOTITE® TAPERED IMPLANT 3.25 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12216068
• Report Number: 0001038806-2021-01351
• Device Sequence Number: 14496415
• Product Code: DZE
• UDI-Device Identifier: 00844868003298
• UDI-Public: (01)00844868003298(17)231217(10)2018112227
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: FNT3213
• Device Catalogue Number: FNT3213
• Device Lot Number: 2018112227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female