MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L); DENTAL IMPLANT

Model Number	BOES506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
Doctor reported necrosis , implant removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) 3i t3 short external hex parallel walled implant, 5mm(d) x 6mm(l) (boes506) was returned for investigation.Visual evaluation of the as returned product identified no malfunction but it did have signs of use and bone attached.However, the boes506 was reported to cause necrosis.The devices could not be functionally tested for the reported event/failure (medical other).Pre-existing conditions noted on the per were disease, penicillin, and low bone density (type iv).The reported device was at tooth location 47 (fdi) for approximately 3 months.Dhr review was completed for the subject lot number, 1236926.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were 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 for similar events and no other complaint was identified.Review completed utilizing keywords: medical other.Therefore, based on the available information, device malfunction has not occurred, and the reported event could not be verified.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16350510
• Report Number: 0001038806-2023-00269
• Device Sequence Number: 6836626
• Product Code: DZE
• UDI-Device Identifier: 00844868033646
• UDI-Public: (01)00844868033646(17)270407(10)2022031054
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: BOES506
• Device Catalogue Number: BOES506
• Device Lot Number: 2022031054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male