MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 11.5MM; DENTAL IMPLANT

Catalog Number	BNPT4311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Sinus Perforation (2277)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.D10.Concomitant medical products bopt5410, 3i t3 tapered implant 5/4 x 10mm, lot 2020021263.
Event or Problem Description
It was reported that patient complaints of pain in sinus after sinus elevation and placement of implants at tooth sites #26 & #25, implants were then removed due to sinus perforation and infection.New placement to follow early next year.Additional appointment required: not indicated.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) bnpt4311, (3i t3 with dcd tapered implant 4/3 x 11.5mm) for evaluation.Visual evaluation was performed, the implant had signs of use with markings from removal.The implants had debris on its external threads.No damage identified or signs of malfunction that would contribute to the event.Measurements match drawing.Dhr review was completed for the subject lot number: 2022040334.No deviations or non-conformance's, 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: 2022040334 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : perforated sinus and dental : medical : infection.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning and patient factors.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable with all the available information provided.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.Similar complaints for implant infection have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformance's.While non-conformance's were identified for some lots during manufacturing record reviews, the documented disposition actions for each did not suggest the likely release of non-conforming product.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.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: 3I T3 WITH DCD TAPERED IMPLANT 4/3 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19790422
• Report Number: 0001038806-2024-01573
• Device Sequence Number: 17177125
• Product Code: DZE
• UDI-Device Identifier: 00844868028338
• UDI-Public: (01)00844868028338(17)270502(10)2022040334
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: BNPT4311
• Device Lot Number: 2022040334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• 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: 07/22/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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 SEE H10 NARRATIVE.; DENTAL IMPLANT SEE H10 NARRATIVE.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic