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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 F2911-06550
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 08/23/2018
Event Type  malfunction  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint. The subject was returned for evaluation but evaluation is still in progress. Upon completion of evaluation, k2m, inc. Will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc. That a screw broke approximately 4-6 month post-operatively.
 
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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
eva james
600 hope parkway se
leesburg, VA 20175
5719192080
MDR Report Key7883023
MDR Text Key120524567
Report Number3004774118-2018-00142
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberF2911-06550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
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

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