MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-02 for CMF SPINALOGIC 01-207-0007 manufactured by Djo, Llc.
[182180610]
No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[182180611]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2020-00007 |
| MDR Report Key | 9774032 |
| Report Source | CONSUMER |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2020-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 3151 SCOTT ST. |
| Manufacturer City | VISTA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMF SPINALOGIC |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 01-207-0007 |
| Catalog Number | 01-207-0007 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |