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

Model Number	MLW3015Z
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Record continues to fail at the ack3 level of submission.Record fails at the ack3 level.A review of the new system revealed this record was not submitted.The system has been providing errors during submission.Correction action ¿ submitted record on day of discovery.Alert vendor of any errors received during the submission of the record for further research and investigation.Preventative action ¿ run report to ensure records have been transmitted by their respective due date.
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: 20558505
• Report Number: 1060818-2024-07230
• Device Sequence Number: 14228829
• Product Code: DZE
• UDI-Device Identifier: 00847236017163
• UDI-Public: 00847236017163
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/04/2024

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: MLW3015Z
• Device Catalogue Number: MLW3015Z
• Device Lot Number: UNKNOWN
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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