MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE¿ TAPERED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	FNT3211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.
Event or Problem Description
Doctor reported that implant fractured at the body of the implant and had to be removed.
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 (1) full osseotite tapered implant 3.25 x 11.5mm (fnt3211) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Fracture identified at threads below platform of implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on an unknown tooth site (fdi) and was used for approximately 8 months, 6 days.Dhr review was completed for the subject lot number (2018112225).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 (2018112225) for similar events and no other complaint was identified.Review completed utilizing keywords: fracture implant.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: FULL OSSEOTITE¿ TAPERED IMPLANT 3.25 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: 15776124
• Report Number: 0001038806-2022-01744
• Device Sequence Number: 17374455
• Product Code: DZE
• UDI-Device Identifier: 00844868003281
• UDI-Public: (01)00844868003281(17)231213(10)2018112225
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/13/2023
• Device Model Number: FNT3211
• Device Catalogue Number: FNT3211
• Device Lot Number: 2018112225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown