MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Catalog Number	OSS485
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that the mount won't come off.The doctor implanted the implant, but the mount did not come off the fixture and the implant fell out.Please investigate and answer.He is scheduled to have an implant inserted in the near future.
Additional Manufacturer Narrative
Zimvie received one (1) oss485, (osseotite® implant 4 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.Dhr review was completed for the subject lot number 2023041042.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 2023041042, for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.The customer did not submit images for the reported event.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 available at the time of this report.

• Brand Name: OSSEOTITE IMPLANT 4 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: 20646323
• Report Number: 0001038806-2024-02616
• Device Sequence Number: 18008355
• Product Code: DZE
• UDI-Device Identifier: 00844868013235
• UDI-Public: (01)00844868013235(17)280515(10)2023041042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: OSS485
• Device Lot Number: 2023041042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/08/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic