MAUDE Adverse Event Report: BIOMET 3I 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 15MM; DENTAL IMPLANT

Model Number	BOST415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that the implant was removed due to infection and allergic reaction.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual inspection of the returned product identified worn markings due to usage and what had the appearance of bone, however no damage identified.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.The returned device was measured and verified to match dhr drawing specifications.The customer is a smoker and clenche the teeth.The reported device was located attooth #29 and was used for approximately 2 months.Pictures or x-ray images were not provided.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Bone loss: a summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.Complainant reported that the implant was removed due to infection and allergic reaction.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative.

• Brand Name: 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 15MM
• 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: 13261402
• Report Number: 0001038806-2022-00063
• Device Sequence Number: 16523706
• Product Code: DZE
• UDI-Device Identifier: 00844868028956
• UDI-Public: (01)00844868028956(17)260324(10)2021030218
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 03/24/2026
• Device Model Number: BOST415
• Device Catalogue Number: BOST415
• Device Lot Number: 2021030218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female