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	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the implant fractured and was removed.A new implant has been placed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).An full osseotiteâ® implant 4 x 11.5mm (fos411) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and bone with fracture at the threads.Device history record (dhr) review was completed for the subject lot number (2016121456).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 was 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 (2016121456) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.

• 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: 14711114
• Report Number: 0001038806-2022-00928
• Device Sequence Number: 5233977
• Product Code: DZE
• UDI-Device Identifier: 00844868003618
• UDI-Public: (01)00844868003618(17)220119(10)2016121456
• 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: 2018
• Device Explanted Year: 2022
• 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): 11/17/2022

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: Lay User/Patient
• Device Expiration Date: 01/19/2022
• Device Model Number: FOS411
• Device Catalogue Number: FOS411
• Device Lot Number: 2016121456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2017
• 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: 53 YR
• Patient Sex: Male