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

Model Number	01-207-0007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2020
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 "used the device since the beginning of january and when she tried it today she heard a popping sound and now the battery is leaking." no further information is currently available.
Additional Manufacturer Narrative
G1, g2: updated manufacturer contact.H2 - h6: device was returned for product evaluation.Device was returned with a swollen battery which did not properly fit within the control box.Device was tested with a known battery in good condition and results within device specifications were observed.

• Brand Name: CMF SPINALOGIC
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9891706
• Report Number: 3012446970-2020-00012
• Device Sequence Number: 13972642
• 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): 03/27/2020

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
• Device Catalogue Number: 01-207-0007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1