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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. LOCKING SCREW INSERTER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 2901-90098
Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 04/20/2020
Event Type  Injury  
Event Description

It was reported that an everest locking screw inserter jammed and an everest polyaxial screw fractured intra-operatively. When the surgeon attempted to remove the screw, the screw head popped off and was stuck on the instrument. There was no surgical delay, however the procedure was not completed successfully as the rod was not able to be connected at the desired level and the screw shaft remained in the patient. This report represents the screw inserter.

 
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Brand NameLOCKING SCREW INSERTER
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key10075639
MDR Text Key191598072
Report Number3004774118-2020-00091
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number2901-90098
Device LOT NumberHRGP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/27/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/20/2020 Patient Sequence Number: 1
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