MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 3.75 X 8.5MM; DENTAL IMPLANT

Catalog Number	XFOS385
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.B7.Other relevant history: allograft and autogenous graft previous to implantation on (b)(6) 2024.
Event or Problem Description
It was reported that implant could not be release from the mount.After follow up, proceeding was completed with another implant.Tooth location 46.
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative zimvie received one (1) xfos385, (osseotite 2 implant 3.75 x 8.5mm) for evaluation.Visual evaluation / functional test was performed, implant shows wear and mount is able to be disengaged from implant as intended.No malfunction identified.Device history record (dhr) review was completed for the subject lot number 2120018365.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 2120018365, for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release a definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The mount is able to be disengaged from implant as intended.The reported event was unconfirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE 2 IMPLANT 3.75 X 8.5MM
• 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: 21319938
• Report Number: 0001038806-2025-00279
• Device Sequence Number: 20812782
• Product Code: DZE
• UDI-Device Identifier: 00844868023821
• UDI-Public: (01)00844868023821(17)290911(10)2120018365
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XFOS385
• Device Lot Number: 2120018365
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• 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: 02/06/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic