MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ EX HEX TAPERED IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	BOET510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth #47 was removed due to infection.Symptoms as a result of the event: inflammation, pain, abscess, suppuration and discomfort.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
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).Upon investigation results the reference was updated to (b)(4).Dhr review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Sterilization record review could not be performed as the lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.A complaint history review by item number was conducted for the ((b)(4) ) dating back to 12 months from the complaint notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.

• Brand Name: 3I T3¿ EX HEX TAPERED IMPLANT 5 X 8.5MM
• 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: 16005776
• Report Number: 0001038806-2022-01931
• Device Sequence Number: 5767283
• Product Code: DZE
• UDI-Device Identifier: 00844868033301
• UDI-Public: (01)00844868033301(17)250129(10)2020010914
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• 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,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: Health Professional
• Device Expiration Date: 01/29/2025
• Device Model Number: BOET510
• Device Catalogue Number: BOET585
• Device Lot Number: 2020010914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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: 55 YR
• Patient Sex: Female