MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS SMARTSHAPE HEALER

Model Number	PGSSHP1
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report covers four (4) malfunction event.A review of the event involved the device(s) experiencing a misalignment issues.No patient adverse event was reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS SMARTSHAPE HEALER
• Common Device Name: SMARTSHAPE HEALER
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• MDR Report Key: 25035955
• Report Number: 1060818-2026-25483
• Device Sequence Number: 15747207
• Product Code: NHA
• UDI-Device Identifier: 00847236026691
• UDI-Public: 00847236026691
• 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): 04/30/2026

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: PGSSHP1
• Device Catalogue Number: PGSSHP1
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• 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