MAUDE Adverse Event Report: BIOMET 3I T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 13MM (L); DENTAL IMPLANT

Catalog Number	T3ST3213
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Concomitant medical products t3st3213, t3 pro non-platform switched tapered implant 3.25mm (d) x 13mm (l) lot 2023020796.
Event or Problem Description
It was reported that the implant failed to integrate due to allergic reaction and was removed.Procedure not completed affected dental positions: #34 and #44.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) t3st3213, (t3 pro non-platform switched tapered implant 3.25mm x 8.5 - 15mm) for evaluation.Visual evaluation was performed.The returned implant has signs of use, apparent bone / tissue attached to external threads.The implant was identified as reported however, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Device history record (dhr) review was completed for the subject lot number 2023020796.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 2023020796 for similar events and one other complaint was identified.Review completed utilizing keywords: dental : medical : allergic reaction.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was probably user caused and patient factors.Therefore, based on the available information, a device malfunction did not occur.Slight wear on the implant was observed, however no damage to the implant was identified that would cause or contribute to the event.The reported event was non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 13MM (L)
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20062938
• Report Number: 0001038806-2024-01924
• Device Sequence Number: 8662374
• Product Code: DZE
• UDI-Device Identifier: 00844868046882
• UDI-Public: (01)00844868046882(17)280303(10)2023020796
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2024

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: T3ST3213
• Device Lot Number: 2023020796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• 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: 08/26/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT.
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic