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U.S. Department of Health and Human Services

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

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K2M INC. EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL FIXATION Back to Search Results
Catalog Number E5112-07545
Device Problems Break (1069); Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 04/19/2018
Event Type  Injury  
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint. The subject product will not be returned for evaluation. Investigation is still in process. When investigation is complete, k2m inc. Will file a supplemental report indicating the findings.

 
Event Description

On (b)(6) 2018 it was reported to k2m, inc. That a surgery took place in which the extended tabs did not function as intended during implantation which led to a significant delay in surgery. Surgery took place (b)(6) 2018. (related to 3004774118-2018-00058).

 
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 subject device was retained by the hospital, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.

 
Event Description

On (b)(4) 2018 it was reported to k2m, inc. That a surgery took place in which the extended tabs broke intra-operatively causing a significant delay in surgery. Surgery took place (b)(6) 2018. (related to 3004774118-2018-00058).

 
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Brand NameEVEREST SPINAL SYSTEM
Type of DevicePEDICLE SCREW SPINAL FIXATION
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 Key7510067
MDR Text Key108093972
Report Number3004774118-2018-00069
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 04/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue NumberE5112-07545
Device LOT NumberFKAY
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 Received04/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/29/2017
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: 05/14/2018 Patient Sequence Number: 1
Treatment
E5112-07550 LOT UNKNOWN
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