MAUDE Adverse Event Report: BIOMET 3I 3I T3® TAPERED IMPLANT 4/3 X 15MM; DENTAL IMPLANT

Model Number	BOPT4315
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported patient stated that her implant was causing pain 24/7.Aet took panos cbct scans to check implant multiple times.- nothing was ever wrong with patient's implant.She sated she believes she may be allergic to metal of implant.Implants were completely integrated.Tooth 15.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One 3i t3â® tapered implant 4/3 x 15mm (bopt4315) and one 3i t3â® tapered implant 5/4 x 13mm (bopt5413) was returned for investigation.Device was measured.Implants had bone and debris attached.The device could not be functionally tested for the reported failure (allergic reaction).Pre-existing condition noted on the per was moderate bone density ¿ type ii.The reported devices have been placed on teeth #13 and 15 (universal).X-ray and picture images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2019010056 and 2021010505).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, 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.Sterilization record (op0210 and op0210) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2019010056 and 2021010505) for similar events and no other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were non-verifiable.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 "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: 3I T3® TAPERED IMPLANT 4/3 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: 15140242
• Report Number: 0001038806-2022-01163
• Device Sequence Number: 20665121
• Product Code: DZE
• UDI-Device Identifier: 00844868029908
• UDI-Public: (01)00844868029908(17)240117(10)2019010056
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2022
• 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): 01/04/2023

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 Expiration Date: 01/17/2024
• Device Model Number: BOPT4315
• Device Catalogue Number: BOPT4315
• Device Lot Number: 2019010056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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 Sex: Female