MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 3.25 X 6.5MM; DENTAL IMPLANT

Model Number	XFOSM365
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external factors (non-design/ non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the implant could not achieve primary stability and was removed.No other implant was placed to complete the procedure.

• Brand Name: OSSEOTITE 2 IMPLANT 3.25 X 6.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10827694
• Report Number: 0001038806-2020-01802
• Device Sequence Number: 14328087
• Product Code: DZE
• UDI-Device Identifier: 00844868024118
• UDI-Public: (01)00844868024118(17)211103(10)2016101464(241)XFOSM365
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2021
• Device Model Number: XFOSM365
• Device Catalogue Number: XFOSM365
• Device Lot Number: 2016101464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR