MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE¿ IMPLANT 5 X 7MM; DENTAL IMPLANT

Catalog Number	FOS507
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical product: fos507, full osseotite¿ implant 5 x 7mm, lot: 2120017980.
Event or Problem Description
It was reported that implants could not be disengage from the mount at tooth positions 16 and 26.Placement of 2 out of 5 implants for full maxillary arch rehabilitation.Notably in 16 and 26 positions, mount would not disengage and applying excessive force to do so risked pushing it into sinus and the implants were left in mouth.After 3 months implants failed to integrate and were removed.Patient will come to complete the procedure placing two implants.This report refers to does not disengage event.
Additional Manufacturer Narrative
Zimvie complaint number (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) fos507, (full osseotite® implant 5 x 7mm) for evaluation.Visual evaluation of the as returned devices identified the implant and bundle mount with signs of use, apparent dried blood attached to the implant's external threads.The mount disengaged from the implant as intended during a functional test.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2120017980.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 2120017980 for similar events and one (1) other complaint was identified.Review completed utilizing keywords: ¿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 and functional testing, a device malfunction did not occur.The reported event was unconfirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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: FULL OSSEOTITE¿ IMPLANT 5 X 7MM
• 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: 22584977
• Report Number: 0001038806-2025-01770
• Device Sequence Number: 11887652
• Product Code: DZE
• UDI-Device Identifier: 00844868003717
• UDI-Public: (01)00844868003717(17)290901(10)2120017980
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063286
• 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): 09/16/2025

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: Other
• Device Catalogue Number: FOS507
• Device Lot Number: 2120017980
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/26/2025
• 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: 07/24/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic