MAUDE Adverse Event Report: ORTHOFIX, LLC BIOSTIM; 5212, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, US

Model Number	5212
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	11/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device did not return for investigation.Spoke to the patient on (b)(6) 2023 and she stated she discontinued treatment.Patient stated weight made her more unstable and warmer.Since stopping treatment she feels more stable and hot spots are gone.Patient stated she did not realize the treatment was going to be a stim devie and she had tried them in the past and they mess up the electrical systems in her body.It was recommended that she reach out to her doctor to inform them she is no longer treating.A review of the dhr for work order (b)(4) and all (b)(4) units from the work order passed final inspection.The review has determined that the risk assessment is still adequate.
Event or Problem Description
Patient called and reported feeling hot spots all over body (side, stomach, thigh) starting a week ago from today.Hips and back were feeling unstable and unable to walk.Hips feel like they are going to give out.Patient discontinued using the device.She was advised to contact her physician and she stated she has not contacted provider.

• Brand Name: BIOSTIM
• Common Device Name: 5212, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, US
• 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: 21680297
• Report Number: 2183449-2025-00014
• Device Sequence Number: 8349430
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• 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): 03/24/2025

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 Expiration Date: 07/18/2023
• Device Model Number: 5212
• Device Catalogue Number: 655212-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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: Other
• Patient Sex: Female