MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	XIFOSS410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that years after loading implant fracture occurred around the collar of the fixture.Fixture was removed.Tooth location 26.
Additional Manufacturer Narrative
Mfr report number 0001038806-2020-01800, section "d4: device udi number" was submitted with udi #(b)(4) in error.Associated lot # 2013100587 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.The following sections have been updated: g7: checked "follow-up.".
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One osseotite® certain® 2 implant 4 x 10mm (xifoss410) was returned for investigation.Visual evaluation of the as returned products identified significant signs of wear and fracturing at the collar.Bone tissue and scratches presented on the external threads which were damaged.Pre-existing patient condition noted on the per was low density ¿ type iv.The reported device was being placed on tooth # 26 (fdi) when the incident occurred.The implant was placed for approximately 4 years 1 month.The reported event could not be recreated and functional testing could not be performed due to the nature of the dental device and event (fracture).X-ray and picture images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2013100587.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2013100587) for similar event and no other complaint was identified.Based on the available information, device malfunction has occurred and the reported event was confirmed.The following sections have been updated: g7: checked "follow-up." h3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 4 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10825285
• Report Number: 0001038806-2020-01800
• Device Sequence Number: 17036455
• Product Code: DZE
• UDI-Device Identifier: 00844868023142
• UDI-Public: (01)00844868023142(17)181114(10)2013100587(241)XIFOSS410
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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: Lay User/Patient
• Device Expiration Date: 11/14/2018
• Device Model Number: XIFOSS410
• Device Catalogue Number: XIFOSS410
• Device Lot Number: 2013100587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 02/10/2021; 02/12/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 02/11/2021; 02/12/2021
• 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: 48 YR