MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	BNSS510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hex of the implant is damaged.They do not know when the damage occurred, but it was discovered when trying to place the final restoration and it would not seat, because the hex in the implant was damaged not allowing it to seat.The implant remains implanted.They replaced it with an angled abutment to work around the issue, but now they have to replace the crown.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.Implant date unknown / not provided.Explant date unknown / not provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) 3i t3 with dcd non-platform switched parallel walled implant 5 x 10mm (bnss510) was not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the applicable instructions for use (ifu), and risk file.Visual / functional testing to recreate the reported event could not be performed due to device not being returned for analysis.A product experience form (per) form was not submitted for this complaint record.A pre-existing condition was not reported on the per form.Bone density unknown.Tooth location is unknown.The customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 2020120137.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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.Complaint history review was performed for the reported lot number 2020120137 for similar events and no other complaint was identified.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, a device malfunctions could not be verified.Without device receipt, the reported event is non-verifiable.

• Brand Name: 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 5 X 10MM
• 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: 16240100
• Report Number: 0001038806-2023-00133
• Device Sequence Number: 6306828
• Product Code: DZE
• UDI-Device Identifier: 00844868029199
• UDI-Public: (01)00844868029199(17)260115(10)2020120137
• 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
• 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): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2026
• Device Model Number: BNSS510
• Device Catalogue Number: BNSS510
• Device Lot Number: 2020120137
• Was Device Available for Evaluation?: No
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2021
• 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
• Patient Sex: Prefer Not To Disclose