MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	FOS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports that the dental implant located in dental position number: #36 failed because it fractured in the body.The doctor confirms that the procedure was not completed with another implant and that the patient did not suffer any negative impact or any unforeseen complications on his health as a result of the event.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional device information unknown /not provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One full osseotiteâ® implant 4 x 11.5mm (fos411) was returned for investigation.Visual evaluation of the as returned implant identified fracture at threads.Device history record (dhr) review for the lot (2016071395) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2016071395) for similar events (complaint category keywords: fracture: implant) and no other complaint was identified therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE® IMPLANT 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: 14653522
• Report Number: 0001038806-2022-00888
• Device Sequence Number: 5693926
• Product Code: DZE
• UDI-Device Identifier: 00844868003618
• UDI-Public: (01)00844868003618(17)210727(10)2016071395
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/27/2021
• Device Model Number: FOS411
• Device Catalogue Number: FOS411
• Device Lot Number: 2016071395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG