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

Model Number	655212-0001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After attempting to contact patient multiples times, customer service was unable to reach patient for return of device.Unable to complete fa.Closed with memo to file.A review of the dhr was performed for work order (b)(4).All (b)(4) units from the work order passed final inspection.Based on the complaint description death or serious injury did not occur and is not likely to cause a death or serious injury if a similar incident was to reoccur.
Event or Problem Description
Patient called customer service and reported that the 655212-0001 spinal stim device gave her a burn.Patient reported that she was wearing a metal wire in her bra and the device burned her where the wire sits.Three attempts via phone call were made to retrieve the device for investigation but we were unable to reach the patient.

• 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: 21655055
• Report Number: 2183449-2025-00010
• Device Sequence Number: 20716839
• Product Code: LOF
• UDI-Device Identifier: 18257200105670
• UDI-Public: 18257200105670
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 07/22/2022
• Device Model Number: 655212-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2021
• 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: 76 YR
• Patient Sex: Female