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

Model Number	S3411
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
Record continues to fail at the ack3 level of submission.

• 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 AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 19442126
• Report Number: 3003631996-2024-00110
• Device Sequence Number: 12818931
• Product Code: DZE
• UDI-Device Identifier: D742S34110
• UDI-Public: D742S34110
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/12/2024

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: S3411
• Device Catalogue Number: S3411
• Device Lot Number: 2007651
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 11/06/2024
• 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