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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 801-36450M
Device Problems Break (1069); Device Issue (2379)
Patient Problem No Information (3190)
Event Date 01/28/2016
Event Type  Malfunction  
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. Since the screw remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained. A review of the manufacturing and inspection records did not reveal any contributing information/trends. Manufacturer is not expecting additional information and therefore considers this to be a closing report. Not returned.

 
Event Description

It was reported to k2m, inc. On (b)(6) 2016 that a surgery took place in which the outer collet of a screw sheared off.

 
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Brand NameMESA SPINAL SYSTEM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
K2M, INC.
751 miller dr se
suite f1
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
751 miller dr se
suite f1
leesburg VA 20175
Manufacturer Contact
sandra gilbert
751 miller dr se
suite f-1
leesburg, VA 20175
5719192000
MDR Report Key5462900
MDR Text Key39108079
Report Number3004774118-2016-00007
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number801-36450M
Device LOT NumberCHGW
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/27/2014
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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