MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® TAPERED IMPLANT 5/4 X 13MM; DENTAL IMPLANT

Model Number	BNPT5413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient weight not provided.Event date not provided.
Event or Problem Description
It was reported that the implant was removed due to pain at the site.The implant was wiggling.Tooth #9.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were updated: 3331.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4315.H10: narrative/data was updated.The reported item was returned for investigation.Visual inspection of the returned product identified worn markings due to usage, however no damage identified.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Measurements were made to determine if the device matched print specifications and confirmed.The reported devices were located on tooth #9 and was used for approximately 1 month.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (2021060508).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record (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 (2021060508) for similar event and no other complaint was identified.Sep post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did not occur, and the reported event was non-verifiable.
Event or Problem Description
No additional event information was received at the time of this report.

• Brand Name: 3I T3® WITH DCD® TAPERED IMPLANT 5/4 X 13MM
• 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: 14652987
• Report Number: 0001038806-2022-00886
• Device Sequence Number: 4868237
• Product Code: DZE
• UDI-Device Identifier: 00844868029489
• UDI-Public: (01)00844868029489(17)260623(10)2021060508
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 06/23/2026
• Device Model Number: BNPT5413
• Device Catalogue Number: BNPT5413
• Device Lot Number: 2021060508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male