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	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported implant fracture at tooth site #36, four (4) years after crown placement.The patient came with the implant fractured at the collar.A new implant was placed three (3 )months after the implant's removal.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient age and date of birth unknown / not provided.Patient weight unknown / not provided.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 osseotiteâ® certainâ® 2 implant 4 x 11.5mm (xifoss411) and one unknown screw were returned for investigation.Visual evaluation of the as returned implant identified fracture at collar with apparent tissue/bone attached to external threads.Fractured screw identified inside implant.Some damage could be from clinician¿s removal of device.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing could not be performed since the implant and screw were fractured.Pre-existing condition noted on the per was low bone density ¿ type iii.The reported device had been placed on tooth 36 (fdi) for approximately 4.5 years.Device history record (dhr) review for the lot (2016021603) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2016021603) for similar events (complaint category keywords: fracture: implant) and no other complaint was identified.Therefore, based on the available information, device malfunction of the implant and screw did occur, and the reported event was confirmed.

• 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: 14956959
• Report Number: 0001038806-2022-01061
• Device Sequence Number: 20182328
• Product Code: DZE
• UDI-Device Identifier: 00844868023159
• UDI-Public: (01)00844868023159(17)210302(10)2016021603
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: XIFOSS411
• Device Catalogue Number: XIFOSS411
• Device Lot Number: 2016021603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2016
• 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 Sex: Male