MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ IMPLANT 3.75 X 10MM; DENTAL IMPLANT

Catalog Number	OSS310
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).E1: reporter name: unknown / not provided.
Event or Problem Description
The doctor reports that the screw-retained crown becomes loose/disengaged, and the screw was replaced.After placing a new crown, it still presents the same issue where the screw does not fit.The implant at tooth site 46 must be explanted due to damaged drive feature in order to place another implant in the future (in 4 to 5 months).This report refers to the damaged drive feature event.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D3: email address.G1: contact office - first/given name, last name and email address.G1: contact office - manufacturer site - email address.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) (b)(6), (osseotite implant 3.75 x 10mm) for evaluation.Visual evaluation was performed, the implant had signs of use with debris on its external threads.Removal damage was identified.The implants drive feature was damaged.Dhr review was completed for the subject lot number 2021090654.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 2021090654 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error, applying to much torque/speed during seating.Therefore, based on the available information, a device malfunction did occur.The implants drive feature was rounded and worn from use.The reported 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.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.

• Brand Name: OSSEOTITE¿ IMPLANT 3.75 X 10MM
• 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: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22910825
• Report Number: 0001038806-2025-02043
• Device Sequence Number: 9266479
• Product Code: DZE
• UDI-Device Identifier: 00844868013105
• UDI-Public: (01)00844868013105(17)260929(10)2021090654
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/14/2025

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: 09/29/2026
• Device Catalogue Number: OSS310
• Device Lot Number: 2021090654
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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: 48 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic