MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	FOS410
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).
Event or Problem Description
It was reported that the implant mount did not disengage from the implant when placing, the implant was removed and another one was placed at the same surgery.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported complaint item was returned for investigation.Visual inspection of the as returned product identified no damage to the implant.However, markings and nicks can be seen on the mount.Also there was excessive wear on the hex of the screw.Functional testing was performed for the returned product and the mount screw was unable to be removed.The length of the device usage is unknown.A device history review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the implant mount did not disengage from the implant when placing.The implant was returned for investigation and the reported complaint is confirmed following inspection and evaluation.A definitive root cause for this complaint could not be determined.The following sections have been updated: h6: evaluation codes; h10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® IMPLANT 4 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9487249
• Report Number: 0001038806-2019-01620
• Device Sequence Number: 1384626
• Product Code: DZE
• UDI-Device Identifier: 00844868003601
• UDI-Public: (01)00844868003601(17)240107(10)2018121132(241)FOS410
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 01/07/2024
• Device Model Number: FOS410
• Device Catalogue Number: FOS410
• Device Lot Number: 2018121132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1