FDA Adverse Event Injury Summary report: N

CMF SPINALOGIC

MDR report key: 9774032 · Received March 2, 2020

Report

Report Number: 3012446970-2020-00007
Event Type: Injury
Date Received: March 2, 2020
Date of Event: February 21, 2020
Report Date: March 30, 2020
Manufacturer: DJO, LLC
Product Code: LOF
UDI-DI: 00888912011495
PMA / PMN Number: P910066
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 1

NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237494	CMF SPINALOGIC	STIMULATOR, BONE GROWTH, NON-INVASIVE	LOF	DJO, LLC	01-207-0007		00888912011495

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention