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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC CMF SPINALOGIC; STIMULATOR, BONE GROWTH, NON-INVASIVE
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DJO, LLC CMF SPINALOGIC; STIMULATOR, BONE GROWTH, NON-INVASIVE Back to Search Results
Model Number 01-207-0007
Device Problems Fluid/Blood Leak (1250); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
 
Event Description
It was reported that the patient "used the device since the beginning of january and when she tried it today she heard a popping sound and now the battery is leaking." no further information is currently available.
 
Manufacturer Narrative
G1, g2: updated manufacturer contact.H2 - h6: device was returned for product evaluation.Device was returned with a swollen battery which did not properly fit within the control box.Device was tested with a known battery in good condition and results within device specifications were observed.
 
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Brand Name
CMF SPINALOGIC
Type of Device
STIMULATOR, BONE GROWTH, NON-INVASIVE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista, ca
MDR Report Key9891706
MDR Text Key193089304
Report Number3012446970-2020-00012
Device Sequence Number1
Product Code LOF
UDI-Device Identifier00888912011495
UDI-Public00888912011495
Combination Product (y/n)N
PMA/PMN Number
P910066
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number01-207-0007
Device Catalogue Number01-207-0007
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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