MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; SPINALOGIC

Model Number	01-207-0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Sus voluntary event report: mw5072830 i had 2 level lumbar surgery l4-s1 on (b)(6) 2017.I was told by the neurosurgeon to use this device for 2 months to help with the fusion/bone growth process.I started on (b)(6) 2017 and stopped after 40 days of daily use.The device automatically shuts off after 30 minutes and allows only daily use.It is programmed.The device covered all of my lumbar and thoracic spine areas.Slowly over this time, i noticed a lot of weakness/pain in the bones especially the sacrum, hips, t-spine and ribs, neck and down to the ankle joints.Around the ankle joint, i feel i would fracture the bone.I also faced extreme fatigue during the time i used this device.It is my belief that it worsened or weakened areas of my spine i.E.Neck and thoracic spine which already have degenerative disc disease/arthritis.

• Brand Name: CHATTANOOGA
• Common Device Name: SPINALOGIC
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7059234
• Report Number: 3012446970-2017-00001
• Device Sequence Number: 1357966
• Product Code: LOF
• UDI-Device Identifier: 00888912011495
• UDI-Public: 00888912011495
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 01-207-0007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other