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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 2901-10001
Device Problem Migration or Expulsion of Device (1395)
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 has not been returned for evaluation. Investigation is still in process. When investigation is complete, k2m inc. Will file a supplemental report indicating the findings. Insitu.

 
Event Description

On (b)(6) 2016 it was reported to k2m, inc. That a patient presented with a set screw back out. The patient reportedly had a set screw back out approximately 3 months post-op. There are no plans to revise at this time as the patient is asymptomatic.

 
Manufacturer Narrative

Comprehensive investigation was immediately initiated on receipt of the complaint. The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case. Since the set screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained. Review of post-op x-rays confirmed that two set screws backed out. While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.

 
Event Description

On (b)(6) 2016 it was reported to (b)(4). That a patient presented with a set screw back out. The patient reportedly had a set screw back out approximately 3 months post-op. There are no plans to revise at this time as the patient is asymptomatic.

 
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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 Key6210802
MDR Text Key63482236
Report Number3004774118-2016-00107
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,Followup
Report Date 11/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number2901-10001
Device LOT NumberUNKNOWN
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 Received11/30/2016
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: 12/28/2016 Patient Sequence Number: 1
Treatment
2901-06550
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