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U.S. Department of Health and Human Services

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

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K2M, INC. EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number F2911-05540
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 11/30/2016
Event Type  Malfunction  
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. The subject product was returned for evaluation but evaluation is still in progress. Upon completion of evaluation of the subject part, k2m inc. Will file a supplemental report indicating the findings.

 
Event Description

On (b)(6) 2016 it was reported to k2m, inc. That a surgery took place in which a screw alignment guide broke during implant insertion casuing a significant delay. Surgery took place (b)(6) 2016.

 
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. The surgeon reportedly had difficulty injecting cement into several everest mi screws due to not having any injector needles. It was reported that the needles were on backorder, so the surgeon decided to use a competitor's product to inject the cement. Consequently, the cement escaped into the screw heads, as opposed to being injected through the distal end of the screws into the patient's bone. The process of removing the escaped cement from the screw heads reportedly extended the surgery by almost an hour. However, the surgeon was reportedly able to complete the case using the alignment guide to inject the cement. There was no reported harm to the patient. In closing, this incident may be attributed to misuse, as the surgery was performed without the proper instrumentation. While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information. In situ.

 
Event Description

On (b)(6) 2016 it was reported to k2m, inc. That a surgery took place in which a polyaxial screw was unable to be implanted as intended, causing a significant delay. Surgery took place (b)(6) 2016.

 
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Brand NameEVEREST 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
5719192000
MDR Report Key6212344
MDR Text Key63619424
Report Number3004774118-2016-00112
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK151727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue NumberF2911-05540
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Date Returned to Manufacturer12/15/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
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 TREATMENT DATA
Date Received: 12/29/2016 Patient Sequence Number: 1
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