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

Model Number	PYMU303
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Abutment wasn't seating properly on implant.Used another abutment to finish procedure.

• 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: 19631983
• Report Number: 1060818-2024-08861
• Device Sequence Number: 15621569
• Product Code: DZE
• UDI-Device Identifier: 00847236006754
• UDI-Public: 00847236006754
• 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
• 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): 07/11/2024

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: PYMU303
• Device Catalogue Number: PYMU303
• Device Lot Number: 2306635
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/28/2024
• Date Device Manufactured: 11/29/2023
• 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