CMF SPINALOGIC 01-207-0007

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number3012446970-2019-00042
MDR Report Key9259387
Report SourceCONSUMER
Date Received2019-10-31
Date of Report2019-10-30
Date of Event2019-10-08
Date Mfgr Received2019-10-08
Date Added to Maude2019-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE TX 75067
Manufacturer CountryUS
Manufacturer Postal75067
Manufacturer G1DJO, LLC
Manufacturer Street3151 SCOTT ST.
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal Code920819663
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCMF SPINALOGIC
Generic NameSTIMULATOR, BONE GROWTH, NON-INVASIVE
Product CodeLOF
Date Received2019-10-31
Model Number01-207-0007
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-31

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