MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	XIFOSS510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the patient has pain weeks after the implant was placed, patient called to report the pain.Patient will return for a new placement at a later date tooth #20.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One osseotite® certain® 2 implant 5 x 10mm (xifoss510) was returned for investigation.Evaluation of the as returned product measured to be in-specification as per the implant print dwg.834011 rev d.Caliper id: cal05593632 due: jun 11, 2021.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was none.The reported device was located on tooth #20 (universal) and was used for approximately 6 days.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot number (2019061442) 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.Complaint history review by lot number (2019061442) was performed for similar events and no other similar complaint was identified.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.The following sections have been updated: g6: checked "follow-up" h3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This submission is being sent to correct an omission to mfr report number 0001038806 - 2020 - 01980.The following sections have been updated: b4: date of this report d9: device availability g4: date received by manufacturer g7: checked "follow-up" h2: checked follow-up type h10: added manufacturer narrative.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10949714
• Report Number: 0001038806-2020-01980
• Device Sequence Number: 641299
• Product Code: DZE
• UDI-Device Identifier: 00844868023210
• UDI-Public: (01)00844868023210(17)240701(10)2019061442(241)XIFOSS510
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2024
• Device Model Number: XIFOSS510
• Device Catalogue Number: XIFOSS510
• Device Lot Number: 2019061442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 03/12/2021; 04/29/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/16/2021; 04/29/2021
• 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: 73 YR