MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® 2 IMPLANT 3.75 X 10MM; DENTAL IMPLANT

Model Number	XFOS310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
It was reported mobility of crown, the doctor verified and found that implant collar was fractured, the remaining part was removed.Patient has been rescheduled for new implant placement.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Supplemental report submitted for email address correction.
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) osseotiteâ® 2 implant 3.75 x 10mm (xfos310) with an unknown biomet screw were returned for investigation.Visual evaluation of the as returned product identified the implant fractured at the collar region.The implant has been damaged, possibly from the removal process.A fractured screw was identified inside the 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 moderate bone density (type ii).The reported implant was located on tooth # 37 (fdi) and was used for approximately 1 year, 5 months.Dhr review was completed for the subject lot number (2019100845).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 (2019100845) for similar events and no other complaint was identified.Review completed utilizing keywords: implant fracture & screw fracture.Based on the available information, device malfunction did occur and the reported events were confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® 2 IMPLANT 3.75 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: 14884022
• Report Number: 0001038806-2022-01018
• Device Sequence Number: 17712835
• Product Code: DZE
• UDI-Device Identifier: 00844868023784
• UDI-Public: (01)00844868023784(17)241025(10)2019100845
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 12/12/2022

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: 10/25/2024
• Device Model Number: XFOS310
• Device Catalogue Number: XFOS310
• Device Lot Number: 2019100845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 12/01/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 09/29/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2019
• 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: 72 YR
• Patient Sex: Male