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

Model Number	BOET410
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
The doctor reports that the mount is welded to the implant.The doctor reports that the patient did not suffer any impact on his health, that the procedure was concluded with another implant and that the affected dental position is 37.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One 3i t3® ex hex tapered implant 4 x 10mm) (boet410) with mount was returned for investigation.Visual evaluation of the as returned implant identified signs of use and but no apparent malfunction identified.Functional testing was performed and mount could be normally disengaged from the implant.Hence, the reported event could not be recreated.Pre-existing patient condition was type ii (moderate) bone density and oral hygiene.The device was attempted to locate on tooth site 37 (fdi) and removed same day.X-rays or picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev h - (b)(6) 2021 information identified: warnings and precautions.Dhr review : dhr review was completed for the subject lot number (2020101303).It was confirmed that all operations and inspections were executed as per applicable procedures.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: complaint history review was completed for the subject lot number (2020101303) for does not disengage/release category and no other complaint was identified.Post market trending review: november post market trending was reviewed and there were no actionable events or corrective actions for the reported event.Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.

• Brand Name: 3I T3® EX HEX TAPERED 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: 12369147
• Report Number: 0001038806-2021-01598
• Device Sequence Number: 11791131
• Product Code: DZE
• UDI-Device Identifier: 00844868033257
• UDI-Public: (01)00844868033257(17)251112(10)2020101303
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 11/12/2025
• Device Model Number: BOET410
• Device Catalogue Number: BOET410
• Device Lot Number: 2020101303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female