MAUDE Adverse Event Report: DJO, LLC CMF SPINALOGIC; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	01-207-0007
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that the patient was sitting in a chair using her spinalogic and she felt something warm.She stood up and immediately removed the device.She took off the device and it had burned two holes into two of her shirts, a t-shirt and a blouse.There was reportedly no patient injury.
Additional Manufacturer Narrative
One spinalogic (product number 01-207-0007, serial number (b)(4) was returned for evaluation.Full treatment was run at test station and a 30-minute battery treatment was run.The product met specifications and did not malfunction.Production records were reviewed and there were no findings that would have contributed to the reported event.The cause of the event could not be determined.

• Brand Name: CMF SPINALOGIC
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8697774
• Report Number: 3012446970-2019-00015
• Device Sequence Number: 2286841
• Product Code: LOF
• UDI-Device Identifier: 00888912011495
• UDI-Public: 00888912011495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 01-207-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1