MAUDE Adverse Event Report: DJO, LLC; SPINALOGIC

Model Number	01-207-0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	07/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
Complaint received that alleges called to tell us that he was diagnosed with renal failure and wanted to know if it was the result of the bone stimulator.We asked him if he had spoken with his doctor and he told us no".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Common Device Name: SPINALOGIC
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 5819004
• Report Number: 2020737-2016-00008
• Device Sequence Number: 16303679
• Product Code: LOF
• UDI-Device Identifier: 00888912011495
• UDI-Public: 00888912011495
• Combination Product (Y/N): N
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2016

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2016
• Initial Report FDA Received Date: 07/25/2016
• 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