MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	XIFOSS413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Weight unknown / not provided.Last name unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported implant removed due to fracture.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-(b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).One osseotite® certain® 2 implant (xifoss413) was returned for investigation.Visual evaluation of the as returned products identified fracture around the implant¿s collar and screw fragment in the implant drive feature.Additionally, there was bone residue around the external threads which were damaged.Functional testing could not be performed due to the nature of the devices and events.Device history record (dhr) review for the lot: (2012121780) 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 zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot: (2012121780) for similar events and no other complaint about nonconforming products was identified.Therefore, based on the available information, implant 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 CERTAIN 2 IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10682548
• Report Number: 0001038806-2020-01565
• Device Sequence Number: 14230530
• Product Code: DZE
• UDI-Device Identifier: 00844868023166
• UDI-Public: (01)00844868023166(17)180117(10)2012121780(241)XIFOSS413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: XIFOSS413
• Device Catalogue Number: XIFOSS413
• Device Lot Number: 2012121780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 12/28/2020; 01/21/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 01/19/2021; 01/28/2021
• 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: 38 YR