MAUDE Adverse Event Report: ORTHOFIX BONE GROWTH STIMULATOR; CERVICALSTIM

Model Number	5505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Dyskinesia (2363)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device did not return for investigation.Device would have expired prior to initial report to manufacturer by patient.
Event or Problem Description
Patient states she began treating in (b)(6) 2023 after cervical surgery.After a few weeks patient stated she experienced spasms on the left side of her face and ear.Patient said she was unsure how long she actually treated but knew it was at least one month.Patient reported having brain surgery in (b)(6) 2023.

• Brand Name: BONE GROWTH STIMULATOR
• Common Device Name: CERVICALSTIM
• Manufacturer (Section D): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 20030579
• Report Number: 2183499-2024-00011
• Device Sequence Number: 8675133
• Product Code: LOF
• UDI-Device Identifier: 18257200105632
• UDI-Public: 18257200105632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 02/28/2024
• Device Model Number: 5505
• Device Catalogue Number: 655505-0001
• 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: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 62 YR
• Patient Sex: Female