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	Calcium Deposits/Calcification (1758)
Date of Event	02/21/2020
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 "began producing (kidney) stones.They were so bad he had to have cysto, lithotripsy and a stint.[sic] he then got a dvt (deep vein thrombosis)." the patient "has to have more treatments for a stone growing in the other kidney since both kidney could not be treated at the same time.[sic] patient's wife "feels it caused him to have 18 kidney stones." the patient has discontinued use of the device.No further information is currently available.
Additional Manufacturer Narrative
H3, h6: one spinalogic (item number 01-207-0007, serial number (b)(6)) was returned for evaluation.Full treatment was ran at test station with magnetometer.The observed results were found within specifications.While running 30 minute battery treatment, device performed as expected.The manufacturer could not duplicate the reported event, no failure was identified.Review of production records found no issues that would be related to the reported problem.

• 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: 9774032
• Report Number: 3012446970-2020-00007
• Device Sequence Number: 16690667
• 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): 03/30/2020

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
• Device Catalogue Number: 01-207-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: Required Intervention