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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M INC. MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM

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K2M INC. MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 6201-35540
Device Problem Device Issue (2379)
Patient Problem No Information (3190)
Event Date 03/27/2018
Event Type  Malfunction  
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. The product was not returned to manufacturer for evaluation, and a thorough investigation was completed as the lot number has been identified/confirmed in this case. Since the screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained. Repeated off-axis engagement of the instrument could have led to instrument deficiencies that might have prevented successful locking of the subject screw.

 
Event Description

On (b)(6) 2018 it was reported to k2m, inc. That a partially locked screw was left in the patient. Surgery took place on (b)(6) 2018.

 
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Brand NameMESA SPINAL SYSTEM
Type of DevicePEDICLE SCREW SPINAL 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
sandra gilbert
600 hope parkway se
leesburg, VA 20175
5719192195
MDR Report Key7445109
MDR Text Key106141407
Report Number3004774118-2018-00046
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143334
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 03/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number6201-35540
Device LOT NumberEKFA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/13/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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