MAUDE Adverse Event Report: BIOMET 3I 3I T3® TAPERED IMPLANT 6/5 X 11.5MM; DENTAL IMPLANT

Model Number	BOPT6511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Paresthesia (4421)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight not provided.
Event or Problem Description
It was reported that the implant failed due to not integrating and the patient having paresthesia at the site.Tooth #30.
Additional Manufacturer Narrative
One (1) 3i t3® tapered implant 6/5 x 11.5mm (bopt6511) was returned for investigation.Visual evaluation of the as returned product identified implant had no apparent malfunction, but signs of use.Product matched print specification where measured (caliper id: cal1831 due: sep 2, 2022).No allegation to abutment.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was paresthesia, moderate bone density (type ii).The reported device was located on tooth # 30 (universal) and was used for approximately 12 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev.H ¿ july 2021.Information identified: contraindications, warnings, precautions, and potential adverse events.Per the applicable ifu, under the section precautions, it is stated that improper technique can lead to implant failure and loss of supporting bone.Dhr review: dhr review was completed for the subject lot number (2021011317).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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record review: sterilization records (op#0210) were reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review: complaint history review was performed for the reported lot number (2021011317) for similar events (complaint category keywords: medical : other) and no other complaint was identified.Post market trending review: feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event (medical : other, paresthesia) or product (bopt6511).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did not occur, and the reported event could not be verified with the information provided.
Event or Problem Description
There is no update to the original complaint description provided.

• Brand Name: 3I T3® TAPERED IMPLANT 6/5 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 ; 5617766700
• MDR Report Key: 12747284
• Report Number: 0001038806-2021-02103
• Device Sequence Number: 4238034
• Product Code: DZE
• UDI-Device Identifier: 00844868029861
• UDI-Public: (01)00844868029861(17)260217(10)2021011317
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/19/2022

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: 02/17/2026
• Device Model Number: BOPT6511
• Device Catalogue Number: BOPT6511
• Device Lot Number: 2021011317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: 35 YR
• Patient Sex: Female