MAUDE Adverse Event Report: BIOHORIZONS INC. BIOHORIZONS INC.; DENTAL IMPLANT

Model Number	TMR4615
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.
Additional Manufacturer Narrative
Corrective actions biohorizons worked with new vendor, sparta, to develop reports to show records showing in a state of open within 7 days of the 30 day reporting date.Preventative actions biohorizons to access daily reports within the biohorizons organization within the new complaint system.As part of client review, sparta is pro-actively monitoring the biohorizons org for records not advancing.During this monitoring, sparta is staying in constant contact with biohorizons of records not advancing and the usage of the newly developed reports for records not showing in a closed state.
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.

• 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: 18975335
• Report Number: 1060818-2024-02784
• Device Sequence Number: 6571594
• Product Code: DZE
• UDI-Device Identifier: 00847236010348
• UDI-Public: 00847236010348
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 09/09/2024

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: TMR4615
• Device Catalogue Number: TMR4615
• Device Lot Number: 2003773
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024; 01/23/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/15/2024; 09/09/2024
• 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