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

Model Number	DT4010STI
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: INTRA-LOCK
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): INTRA-LOCK; 2300 riverchase ctr.; birmingham AL 35244
• Manufacturer Contact: ansissa smith
• MDR Report Key: 21737956
• Report Number: 3003631996-2025-00338
• Device Sequence Number: 8734763
• Product Code: DZE
• UDI-Device Identifier: D742DT4010STI
• UDI-Public: D742DT4010STI
• 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: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: DT4010STI
• Device Catalogue Number: DT4010STI
• Device Lot Number: AH875
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 04/01/2025
• 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