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

Model Number	5505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Numbness (2415); Neck Pain (2433)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch report: mw585017 was received 4/10/2026.Patient reported developing severe neuralgia pain and numbness in left shoulder, left arm to hand, with increased weakness, and increased numbness in right hand and pain in neck.Patient reported it took almost a week for most symptoms to resolve and still was symptomatic for an additional week or two.After a follow up call to the patient was made on (b)(6) 2026 patient reported feeling normal but has discontinued use of the device.
Additional Manufacturer Narrative
The device was returned for investigation but the analysis is incomplete.A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
Medwatch report mw585017 was received 4/10/2026.Patient reported developing severe neuralgia pain and numbness in left shoulder, left arm to hand, with increased weakness, and increased numbness in right hand and pain in neck.Patient reported it took almost a week for most symptoms to resolve and still was sympotmatic for an additional week or two.After a follow up call to the patient was made on 4/20/2026 patient reported feeling normal but has discontinued use of the device.
Additional Manufacturer Narrative
The device was returned for investigation.Non-orthofix power supply was returned.Power supply was not returned for fa.Confirmed device met design specification and worked as intended.A review of the dhr was performed and all devices passed final inspection.

• Brand Name: OSTEOGENESIS STIMULATOR, CERVICAL-STIM
• 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: 25070486
• Report Number: 2183449-2026-00017
• Device Sequence Number: 21450302
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/15/2026

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: 5505
• Device Catalogue Number: 655505-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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: 67 YR
• Patient Sex: Female