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

Model Number	DT4008STI
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The processor misinterpreted the assignment, resulting in an unintentional omission.This is highly uncommon, as they typically complete over 600 submissions monthly.To prevent future errors, the assignment calendar has been simplified and dual oversight added.
Event or Problem Description
Implant failed to osseointegrate.
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: INTRA-LOCK INTERNATIONAL, INC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): INTRA-LOCK INTERNATIONAL, INC; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): INTRA-LOCK INTERNATIONAL, INC.; 2300 riverchase center; birmingham 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham 35244
• MDR Report Key: 24447162
• Report Number: 3003631996-2026-00515
• Device Sequence Number: 16005529
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/16/2026

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: DT4008STI
• Device Catalogue Number: DT4008STI
• Device Lot Number: AO849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 07/07/2026
• 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