MAUDE Adverse Event Report: ORTHOFIX, LLC PEMF - SPINAL STIM; BONE GROWTH STIMULATOR

Model Number	655212-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysuria (2684); Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, there is no cause established.Patient reported physicians he consulted were unsure what was contributing to the symptoms experienced.No additional information was provided and the device is not available for further investigation.
Event or Problem Description
Patient reported that bladder function was lost during device treatment plan after 4 times of use.Patient had a catheter inserted and after 7 days, it was removed but patient could not urinate without catheter.Another catheter was inserted for 10 days and once removed, patient could urinate but had no bladder control.Patient discontinued use of device as advised my physician.

• Brand Name: PEMF - SPINAL STIM
• Common Device Name: BONE GROWTH STIMULATOR
• 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: 23835261
• Report Number: 2183449-2025-00043
• Device Sequence Number: 9268572
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/17/2025

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: 655212-0001
• Device Catalogue Number: 5212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• 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: 68 YR
• Patient Sex: Male