MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 6 X 8.5MM; DENTAL IMPLANT

Model Number	XIFNT685
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Swelling (2091); No Code Available (3191)
Date of Event	04/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age: not provided.Initial reporter fax number: not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported that implant (xifnt685) was removed due to infection after one week of implant placement.Patient complain of swelling and bleeding.
Event or Problem Description
Additional information has been received from the customer confirming this event as non-integration.Clarification was received confirming that non complication were found after implant placement.One week later implant felt loose and it failed to integrate.Irritation was noted.Tooth location 20.As a result, event has been reassessed.
Additional Manufacturer Narrative
Additional information has been received from the customer confirming this event as non-integration.Clarification was received confirming that non complication were found after implant placement.One week later implant felt loose and it failed to integrate.Irritation was noted.Upon reassessment of the reported event, it was determined that the non-integration/ loss integration event no longer meets the criteria of a reportable event.The event is clinically known, risks are acceptable in terms of individual patient benefit, clearly identified within labeling, and occurs within a quantitative occurrence that is monitored monthly.As a result, no further medwatch reports will be submitted for this file.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 6 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10285979
• Report Number: 0001038806-2020-01000
• Device Sequence Number: 19502821
• Product Code: DZE
• UDI-Device Identifier: 00844868022091
• UDI-Public: (01)00844868022091(17)231010(10)2018092088(241)XIFNT685
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: Lay User/Patient
• Device Expiration Date: 10/10/2023
• Device Model Number: XIFNT685
• Device Catalogue Number: XIFNT685
• Device Lot Number: 2018092088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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 Weight: 70