MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	XIFOSS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that implant was placed without any issues during surgical and prosthetic phase.Patient came to regular check ups.One day crown fell and doctor noticed that the reason was the implant fracture.Implant was removed and a new one was placed in the same procedure.
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) during product evaluation it was determined that the implant fractured did not match the prints for a xifoss411.Instead the implant was identified as an unknown biomet implant.
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) unknown biomet implant was returned for investigation.Visual evaluation of the as returned implant identified fracture across the middle.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Pre-existing conditions noted on the per were bruxism and low bone density (type iii).The reported device was in tooth location 36 (fdi) and was used for approximately 2 years, 6 months.Device history record (dhr) and complaint history review could not be performed, as the subject lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed as physical evaluation identified the fractured implant.

• Brand Name: OSSEOTITE® CERTAIN® 2 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: 14884091
• Report Number: 0001038806-2022-01019
• Device Sequence Number: 20387412
• Product Code: DZE
• UDI-Device Identifier: 00844868023159
• UDI-Public: (01)00844868023159(17)240121(10)2019010528
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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 Model Number: XIFOSS411
• Device Catalogue Number: XIFOSS411
• Device Lot Number: 2019010528
• 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: 10/10/2022; 12/03/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 10/19/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• 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: 53 YR
• Patient Sex: Male