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

Model Number	IFNT413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the implant #13 was placed (b)(6) 2018 and patient came in as an emergency with pain on (b)(6) 2019 and implant was removed.Additional appointments / implant re-placement: not indicated.As a result of this event, no injury to the patient reported.Symptoms as a result of the event: none reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One full osseotite® tapered certain® implant 4 x 13mm (ifnt413) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use and risk files to address reported event.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No any pre-existing conditions noted.The reported device was located on tooth #13 and was used for approximately 1 year.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot number: (2017120714) 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: (2017120714) was performed for similar events and no other similar complaint was identified.Based on the available information, device malfunction and the reported events could not be verified as the exact details of event were non-verifiable and the product was not returned.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative h3 other text: device not returned.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN 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: 11235784
• Report Number: 0001038806-2021-00120
• Device Sequence Number: 14414499
• Product Code: DZE
• UDI-Device Identifier: 00844868005025
• UDI-Public: (01)00844868005025(17)230103(10)2017120714(241)IFNT413
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 01/03/2023
• Device Model Number: IFNT413
• Device Catalogue Number: IFNT413
• Device Lot Number: 2017120714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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