MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® 2 IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	XFOSM311
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).
Event or Problem Description
It was reported that the dental implant failed due to a malfunction in the hexagon.The doctor reported that the procedure was completed with another implant on the same day and that the patient did not suffer any negative impact on his health.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One implant was returned for investigation.Visual evaluation of the as returned implant identified damage around the platform and internal hex.Additionally, the implant collar was damaged possibly during removal process.Functional testing was not performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported implant was intended for an unknown tooth location.Picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08/01.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, it is stated that improper technique and overloading may lead to device failure.Dhr review: dhr review for the lot (2019012053) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019012053) for similar events (complaint category keywords: damaged drive feature) and no other complaint was identified.Post market trending review: august post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.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: OSSEOTITE® 2 IMPLANT 3.25 X 11.5MM
• 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: 14587987
• Report Number: 0001038806-2022-00833
• Device Sequence Number: 5555462
• Product Code: DZE
• UDI-Device Identifier: 00844868024033
• UDI-Public: (01)00844868024033(17)240209(10)2019012053
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/18/2022

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: 02/09/2024
• Device Model Number: XFOSM311
• Device Catalogue Number: XFOSM311
• Device Lot Number: 2019012053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2019
• 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 Sex: Male