MAUDE Adverse Event Report: BIOMET 3I 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	BOES410
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr.Indicated malfunction.The doctor tried to remove the mount, but it did not come off and the implant body was removed.It has been treated and is not re-embedded.Scheduled to be embedded at a later date.No health hazard.Malfunction, does not come off the mount.Tooth site # 30.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) 3i t3â® ex hex parallel walled implant 4 x 10mm (boes410) was returned for investigation.Visual evaluation of the as returned product identified damage mount and drive feature of the mount.Unable to separate.Functional testing to recreate the reported event, verified the devices do not disengage.Additionally, the coob could not be verified.Pre-existing conditions noted on the per was moderate bone density (type ii), bruxism, clenching, malocclusion.The reported device was located on tooth # 30 (universal) and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2018070989).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.Complaint history review was performed for the reported lot number (2018070989) for similar events and no other complaint was identified.July post market trending was reviewed and there were no actionable events or corrective actions for the reported event.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 occur and the reported event was confirmed.Additionally, the coob could not be verified as the product was used, and the conditions when it was received are unknown / non-verifiable.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes.

• Brand Name: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 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: 14046121
• Report Number: 0001038806-2022-00504
• Device Sequence Number: 4895020
• Product Code: DZE
• UDI-Device Identifier: 00844868032441
• UDI-Public: (01)00844868032441(17)230723(10)2018070989
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133049
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: BOES410
• Device Catalogue Number: BOES410
• Device Lot Number: 2018070989
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2018
• 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: 55 YR
• Patient Sex: Male