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

Model Number	BNPT4311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to poor implant placement due to poor stability of the surgical splint, lingual perforation occurred, and the implant was removed.Tooth location 31.Implant placed at 80 n torque and 800 rpm.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
The complaint reported that due to poor implant placement due to poor stability of the surgical splint, lingual perforation occurred, and the implant was removed.Tooth location 47.Implant placed at 80 n torque and 800 rpm.One 3i t3 with dcd tapered implant, (bnpt4311) was returned for investigation (see images attached).Visual/physical evaluation of the as returned product identified signs of use but no apparent signs of malfunction.Functional testing could not be performed due to that nature of the device and event.Dhr review was completed for the subject lot number 2022010192.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 2022010192 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Review of appropriate documentation: per the applicable ifu, ¿biomet 3i dental implants should not be placed in patients where the remaining jawbone is too diminished to provide adequate implant stability¿.Based on the investigation and risk management file review, the most likely root causes determined from the investigation were improper techniques used and patient factors.Therefore, based on the available information, device malfunction has not occurred.Additionally, the reported event could not be verified as the exact details of event were unknown/unverifiable.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
It was reported that due to poor implant placement due to poor stability of the surgical splint, lingual perforation occurred and the implant was removed.Tooth location 31.Implant placed at 80 n torque and 800 rpm.

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16675361
• Report Number: 0001038806-2023-00658
• Device Sequence Number: 12099142
• Product Code: DZE
• UDI-Device Identifier: 00844868028338
• UDI-Public: (01)00844868028338(17)270405(10)2022010192
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: 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): 08/29/2023

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: Other
• Device Model Number: BNPT4311
• Device Catalogue Number: BNPT4311
• Device Lot Number: 2022010192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic