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

Catalog Number	XIFOSS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth site #36 was removed due to fracture.A loss of integration was noted, in addition to implant mobility.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation code was added: 10, 4109, 3331, 4111.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported device for evaluation.Visual evaluation was performed, the implant had signs of use with bone debris on the external threads.The implants platform was fractured off.The fractured piece was returned.A fractured screw fragment was identified stuck inside the implant.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events, and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors - occlusal loading.Therefore, based on the available information, a device malfunction did occur.The implant was fractured.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22688926
• Report Number: 0001038806-2025-01840
• Device Sequence Number: 15681548
• Product Code: DZE
• UDI-Device Identifier: 00844868023159
• UDI-Public: (01)00844868023159(17)201213(10)2015120012
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K100724
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: Other
• Device Expiration Date: 12/13/2020
• Device Catalogue Number: XIFOSS411
• Device Lot Number: 2015120012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic