MAUDE Adverse Event Report: INTRA-LOCK INTERNATIONAL INTRA-LOCK INTERNATIONAL; DENTAL IMPLANT

Model Number	DT4011STI
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: INTRA-LOCK INTERNATIONAL
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): INTRA-LOCK INTERNATIONAL; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): INTRA-LOCK INTERNATIONAL, INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 23182463
• Report Number: 3003631996-2025-00444
• Device Sequence Number: 21118646
• Product Code: DZE
• UDI-Device Identifier: D742DT4011STI0
• UDI-Public: D742DT4011STI0
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: Health Professional
• Device Model Number: DT4011STI
• Device Catalogue Number: DT4011STI
• Device Lot Number: AM186
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown