MAUDE Adverse Event Report: BIOMET 3I CERTAIN TITANIUM LARGE HEXED SCREW; DENTAL IMPLANT

Catalog Number	ILRGHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A3: gender unknown / not provided.A4: patient weight unknown / not provided.D9: device availability unknown / not provided.D10.Concomitant medical products ilrghg, certain gold-tite large hexed screw lot 1232658.G4: premarket identification k072642.
Event or Problem Description
It was reported the fractures of two screws at tooth site 36/37.Crown mobility due to screw fracture.Implants are still placed on the patient.Screws placed on (b)(6) 2020 and removed on (b)(6) 2025.The process was not completed.No impact on the patient reported.
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.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 did not receive one (1) ilrght, (certain titanium large hexed screw) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Device history record (dhr) review was completed for the subject lot number 1281722.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 1281722 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: fracture: screw.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.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: CERTAIN TITANIUM LARGE HEXED SCREW
• 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: 22165964
• Report Number: 0001038806-2025-01306
• Device Sequence Number: 7789342
• Product Code: DZE
• UDI-Device Identifier: 00844868006138
• UDI-Public: (01)00844868006138(17)290506(10)1281722
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K972444
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/21/2025

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: ILRGHT
• Device Lot Number: 1281722
• Was Device Available for Evaluation?: No
• 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: 06/09/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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 SCREW.
• Patient Age: 49 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic