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

Model Number	BNPT6511
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported by customer that the implant was removed due to allergic reaction.Discomfort after healing, patient requested removal.Pain was reported.Patient will return for an additional appointment.Tooth# 15.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) 3i t3® with dcd® tapered implant 6/5 x 11.5mm (bnpt6511) & one (1) 3i t3â® with dcdâ® tapered implant 6/5 x 13mm (bnpt6513) were returned for investigation.Visual evaluation of the as returned product identified bone debris on the external threads, but no apparent malfunction with the returned implants.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 unknown bone density type.The reported devices were located on tooth sites # 14, 15 (universal) and were used for approximately 3 years, and 7 months.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot numbers (2017031607 & 2013071866).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 numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2017031607 & 2013071866) for similar events and no other complaint was identified.Based on the available information and dimensional analysis, device malfunction did not occur.The reported event could not be verified as the exact details of event and patient anatomical conditions were unknown/non-verifiable.The following sections have been updated: g6: checked "follow-up".H3: changed "no" to "yes".

• Brand Name: 3I T3® WITH DCD® 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: 12972994
• Report Number: 0001038806-2021-02316
• Device Sequence Number: 11841432
• Product Code: DZE
• UDI-Device Identifier: 00844868029519
• UDI-Public: (01)00844868029519(17)220405(10)2017031607
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 04/05/2022
• Device Model Number: BNPT6511
• Device Catalogue Number: BNPT6511
• Device Lot Number: 2017031607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2017
• 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: 69 YR
• Patient Sex: Male