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

Model Number	01-207-0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Vision (2139)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
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 is experiencing loss of vision after treatments with her spinalogic bone growth stimulator.It is unknown whether the loss of vision is permanent or temporary.Further information has been requested, but no response has been provided.
Additional Manufacturer Narrative
One cmf spinalogic item number (b)(4), serial number (b)(4), was returned for evaluation.A full treatment was run at test station.Observed results were within specifications.A 30-minute battery treatment was run; device performed as expected.Quality assurance technician wore the device during the 30-minute treatment session with no discomfort or loss of vision during or after treatment.The product met specifications and did not malfunction.

• 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: 9259387
• Report Number: 3012446970-2019-00042
• Device Sequence Number: 2055204
• 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): 12/23/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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