MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS 3.0MM SMARTSHAPE HEALER

Model Number	PYMU1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report indicates one (1) malfunction event.A review of the event involved of the device(s) experiencing fitting issues.No patient adverse event was reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS 3.0MM SMARTSHAPE HEALER
• Common Device Name: 3.0MM SMARTSHAPE HEALER
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• MDR Report Key: 24227168
• Report Number: 1060818-2026-25449
• Device Sequence Number: 9366934
• Product Code: NHA
• UDI-Device Identifier: 00847236026820
• UDI-Public: 00847236026820
• Combination Product (Y/N): N
• PMA/510(K) Number: K240531
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PYMU1
• Device Catalogue Number: PYMU1
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• 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
• Patient Sex: Unknown