MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD, 5MM(D) X 5MM(L); DENTAL IMPLANT

Model Number	BNES505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that can't remove mount.After the mount was implanted, it did not come off.According to the doctor, it is not tightened with a particularly strong torque value.No health hazard.Tooth site # 30.
Additional Manufacturer Narrative
Zimvie received one (1) bnes505, (3i t3® short external hex parallel walled implant with dcd®, 5mm(d) x 5mm(l)) for evaluation.Visual evaluation of the as reported device identified the implant with signs of use.Functional testing to recreate the reported event verified the mount disengaged from the implant as intended.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2021120123.No deviations or non-conformances, 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 2021120123 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿does not disengage/release.¿ the customer did submit one (1) image for the reported event.(image attached) ifu review: documents reviewed: biomet 3i dental implant ifu p-iis086gi rev.J 2022/08.Information identified: "warnings" & "contraindications" based on the investigation and risk management file review as per rmf rm-00053-haz rev.11, the most likely root causes determined from the investigation are torque applied during placement/seating exceeds recommended value, internal thread of implant length is too short preventing mount screw from fully seating.Therefore, based on the available information, and functional testing a device malfunction did not occur.The reported event was unconfirmed with all the available information.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
No further event information available at the time of this report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD, 5MM(D) X 5MM(L)
• 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: 16872436
• Report Number: 0001038806-2023-00854
• Device Sequence Number: 14817757
• Product Code: DZE
• UDI-Device Identifier: 00844868033592
• UDI-Public: (01)00844868033592(17)261217(10)2021120123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150571
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/17/2023

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: BNES505
• Device Catalogue Number: BNES505
• Device Lot Number: 2021120123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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 Age: 65 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic