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

Model Number	TLX5812
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
Biohorizons is notifying fda that one or more emdr submissions could not be transmitted within the required reporting timeframe due to an unexpected system outage affecting our complaint management and reporting process.The outage was between 07/23/2026 and 07/31/2026.To cover the delay in processing an internal deviation as opened dv26029.The issue was escalated through our service providers under ticket numbers honeywell sparta: 01206739 and salesforce: 474165522, and restoration activities were actively underway.As of the escalation, the outage had persisted for seven working days (07/23 to 07/31/2026) and impacted our ability to complete electronic submissions.Biohorizons identified the affected reportable events, maintained documentation of the outage, and monitored the status of corrective actions to restore system functionality.Upon restoration of the system, all delayed emdr submissions will be transmitted as soon as practicable.We are documenting this event within our quality system and evaluating any additional corrective or preventive actions necessary to prevent recurrence.Biohorizons remains committed to compliance with 21 cfr part 803 reporting requirements and is providing this notification to document the circumstances that temporarily prevented electronic submission of required emdr reports.

• 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: 50121934
• Report Number: 1060818-2026-15650
• Device Sequence Number: 10078303
• Product Code: DZE
• UDI-Device Identifier: 00847236010164
• UDI-Public: 00847236010164
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K223697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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,Followup
• Report Date (Section B): 08/31/2026

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: TLX5812
• Device Catalogue Number: TLX5812
• Device Lot Number: 2303185
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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