MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	XIFOSS485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).The reported event of the implant being unable to be placed into the osteotomy and/or lacking primary stability is likely due to the patient bone quality (pre-existing condition) or the surgical technique.There is no reported malfunction and/or deficiency of the implant and there is no indication that the implant has caused or contributed to the failed attempt to place the implant.More than 800 complaints related to this event have been investigated since (b)(6) 2017 and, out of these investigations, no signals indicating potential manufacturing non-conformances affecting primary stability have been identified.Therefore, this event has been deemed not reportable.Summary investigation.
Event or Problem Description
It was reported that the implant xifoss485 lacked primary stability when placing and it was removed.Patient will have to go back to the practice to place a new implant.Dental site 13.

• Brand Name: OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9994895
• Report Number: 0001038806-2020-00736
• Device Sequence Number: 4597632
• Product Code: DZE
• UDI-Device Identifier: 00844868023203
• UDI-Public: (01)00844868023203(17)231123(10)2018110809(241)XIFOSS485
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100724
• 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): 04/24/2020

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: 11/23/2023
• Device Model Number: XIFOSS485
• Device Catalogue Number: XIFOSS485
• Device Lot Number: 2018110809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/24/2020
• 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: 78 YR