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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS, INC. INTRACEPT ACCESS INSTRUMENTS; PROBE, RADIOFREQUENCY LESION AND ACCESSORIES

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RELIEVANT MEDSYSTEMS, INC. INTRACEPT ACCESS INSTRUMENTS; PROBE, RADIOFREQUENCY LESION AND ACCESSORIES Back to Search Results
Model Number FG 0060
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Spinal Column Injury (2081); Vertebral Fracture (4520)
Event Type  Injury  
Event Description
Patient had a l3 compression fracture 61 days post-op.Patient was subsequently treated with a l3 kyphoplasty/teriparatide.Intracept treatment occurred on l1-l3 levels.
 
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Brand Name
INTRACEPT ACCESS INSTRUMENTS
Type of Device
PROBE, RADIOFREQUENCY LESION AND ACCESSORIES
Manufacturer (Section D)
RELIEVANT MEDSYSTEMS, INC.
1230 midas way
suite 200
sunnyvale CA 94085 4068
Manufacturer Contact
thomas slater
1230 midas way
suite 200
sunnyvale, CA 94085-4068
6503681000
MDR Report Key14740041
MDR Text Key294486822
Report Number3006789852-2022-00007
Device Sequence Number1
Product Code GXI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberFG 0060
Device Catalogue NumberRLV AK05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2022
Initial Date FDA Received06/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age84 YR
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