MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® TAPERED IMPLANT 5/4 X 11.5MM; DENTAL IMPLANT

Model Number	BNPT5411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth location #13 was stable with no signs of infection, but the patient reported increasing pain.The implant was removed.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.H6: investigation type codes were added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.One 3i t3â® with dcdâ® tapered implant 5/4 x 11.5mm was returned for investigation.Implant shows minor signs of use.Implant matched print when measure using caliper.No malfunction was noticed during product evaluation that will contribute to the event.Based on the evaluation and dimensional analysis, device malfunction has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse events or actionable trends for the reported event or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review for the lot number (2021090960) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported event.All sterilization activities were conducted with no nonconformities per sterilization record (op0210).Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review was performed for the reported lot number (2021090960) for similar events (complaint category keywords: pain) and no other complaint was identified.The device could not be functionally tested for the reported failure (pain).The reported event could not be recreated.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation is patient specific issue (i.E.Allergies, reactions) or improper techniques used during treatment.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: 3I T3® WITH DCD® TAPERED IMPLANT 5/4 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: 14514479
• Report Number: 0001038806-2022-00777
• Device Sequence Number: 12147319
• Product Code: DZE
• UDI-Device Identifier: 00844868028376
• UDI-Public: (01)00844868028376(17)261014(10)2021090960
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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 Model Number: BNPT5411
• Device Catalogue Number: BNPT5411
• Device Lot Number: 2021090960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female