MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	FNT510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that at the time of using the ratchet, the carrier broke the hexagon of the implant head.The procedure was concluded with another implant.The doctor informs that the patient had already regenerated the bone previously and that the patient did not suffer any impact on his health.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One full osseotite® tapered implant 5 x 10mm (fnt510) was returned for investigation.Visual evaluation of the as returned product, identified damaged external hex and platform being worn out.Implant external threads were damaged as well.Functional testing to recreate the reported event could not be performed, due to the nature of the device & event.Pre-existing conditions noted, on the per was type i (high) bone density and oral hygiene.The implant had been placed on tooth site 47 (fdi) and event occurred, during clinical procedure.Device history record (dhr) review was completed for the subject lot number 2019031092.It was confirmed, that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted, as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (2019031092) was performed, for similar event using keyword category 'damaged drive feature'.And no complaint about nonconforming products was identified.September post market trending was reviewed.And there were no actionable events or corrective actions for the reported event (damaged drive feature) or products (fnt510).Therefore, based on the available information, device malfunction did occur.And the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® TAPERED IMPLANT 5 X 10MM
• 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: 12335399
• Report Number: 0001038806-2021-01551
• Device Sequence Number: 3001947
• Product Code: DZE
• UDI-Device Identifier: 00844868003373
• UDI-Public: (01)00844868003373(17)240325(10)2019031092
• 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): 11/25/2021

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: 03/25/2024
• Device Model Number: FNT510
• Device Catalogue Number: FNT510
• Device Lot Number: 2019031092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• 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: 07/26/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• 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: 48 YR
• Patient Sex: Male