MAUDE Adverse Event Report: ORTHOFIX, LLC BIOSTIM; OSTEOGENESIS STIMULATOR, CERVICAL-STIM

Model Number	655505-0001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not yet returned for investigation.When the device becomes available it will be investigatied at that time.A review of the dhr was performed - all 60 units from this work order passed final inspection.
Event or Problem Description
Patient called and reported a burning sensation causing the treatment area to blister.Patient stated she skipped a treatment day and felt some relief and when she started treating again, she experienced the similar issue.

• Brand Name: BIOSTIM
• Common Device Name: OSTEOGENESIS STIMULATOR, CERVICAL-STIM
• Manufacturer (Section D): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX, LLC; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 23064691
• Report Number: 2183449-2025-00027
• Device Sequence Number: 9849811
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P850007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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: Lay User/Patient
• Device Model Number: 655505-0001
• Device Catalogue Number: 5505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female