MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-31 for CMF SPINALOGIC 01-207-0007 manufactured by Djo, Llc.
Report Number | 3012446970-2019-00042 |
MDR Report Key | 9259387 |
Report Source | CONSUMER |
Date Received | 2019-10-31 |
Date of Report | 2019-10-30 |
Date of Event | 2019-10-08 |
Date Mfgr Received | 2019-10-08 |
Date Added to Maude | 2019-10-31 |
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 | MR. BRIAN BECKER |
Manufacturer Street | 2900 LAKE VISTA DRIVE |
Manufacturer City | LEWISVILLE TX 75067 |
Manufacturer Country | US |
Manufacturer Postal | 75067 |
Manufacturer G1 | DJO, LLC |
Manufacturer Street | 3151 SCOTT ST. |
Manufacturer City | VISTA CA 920819663 |
Manufacturer Country | US |
Manufacturer Postal Code | 920819663 |
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 | 2019-10-31 |
Model Number | 01-207-0007 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DJO, LLC |
Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-10-31 |