MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Catalog Number	BNST511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor saw this patient in september 2023, complaining about soreness around the implant at tooth location #30.The doctor prescribed antibiotics for infection and cleaned around the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).B3: sometime in (b)(6) 2023.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.H3 other text : summary investigation.
Event or Problem Description
Upon investigation, the returned implant was found to be fractured.
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.B5: event description was updated.D9: device availability and return date were 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 code was added: 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation was performed, damage to the implant was identified the implant was fractured at the collar.Dhr review was completed for the subject lot number 2021101317.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2021101317 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the clinician selected an implant that is unable to resist long-term occlusal loading.Therefore, based on the available information, device malfunction did occur.The implant was fractured at the collar.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: 3I T3 WITH DCD NON-PLATFORM SWITCHED TAPERED IMPLANT 5 X 11.5MM
• 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 ; 5619713230
• MDR Report Key: 18325123
• Report Number: 0001038806-2023-02429
• Device Sequence Number: 12602173
• Product Code: DZE
• UDI-Device Identifier: 00844868029304
• UDI-Public: (01)00844868029304(17)261112(10)2021101317
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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 Catalogue Number: BNST511
• Device Lot Number: 2021101317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Patient Ethnicity: Non Hispanic