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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL RESOURCES, INC. SWEDGE PEDICLE SCREW FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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SPINAL RESOURCES, INC. SWEDGE PEDICLE SCREW FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number LC-03
Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 05/11/2020
Event Type  malfunction  
Event Description
Removal of previous implant hardware from previous surgery. Locking caps intended to be removable but were unable to be removed led to additional surgical maneuvers.
 
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Brand NameSWEDGE PEDICLE SCREW FIXATION SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
SPINAL RESOURCES, INC.
5975 north federal highway suite 250
fort lauderdale FL 33308
MDR Report Key10086623
MDR Text Key191976708
Report Number10086623
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberLC-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2020
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer05/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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