MAUDE Adverse Event Report: BioHorizons Inc. BioHorizons Inc.; Dental Implant

Model Number	TMR5812
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
The initial emdr record was due for submission on june 27, 2026.However, the associated reportability assessment¿the controlling record for submission¿was not completed by the processor until august 14, 2026.As a result, the delayed completion of the reportability assessment record directly contributed to the late submission of the emdr.A reminder has been communicated to the processor emphasizing the importance of completing reportability assessments on or before the assigned due date to ensure timely regulatory reporting.

• Brand Name: BioHorizons Inc.
• Common Device Name: Dental Implant
• Manufacturer (Section D): BioHorizons Inc.; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BioHorizons Inc.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 50472212
• Report Number: 1060818-2026-17365
• Device Sequence Number: 13322299
• Product Code: DZE
• UDI-Device Identifier: 00847236010386
• UDI-Public: 00847236010386
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: IT
• PMA/510(K) Number: K223697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• 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): 07/19/2026

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: TMR5812
• Device Catalogue Number: TMR5812
• Device Lot Number: 1003330
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 08/27/2026
• 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