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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 2901-86055YA
Device Problem Bent (1059)
Patient Problems Unspecified Infection (1930); Pain (1994); Paralysis (1997)
Event Date 05/14/2018
Event Type  Injury  
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) 2018 it was reported to k2m, inc. That a patient presented with a backed-out set screw and offset connector and a bent side connector approximately a month post-operatively. As a result, the patient was revised on (b)(6) 2018. (related to 3004774118-2018-00073 and 3004774118-2018-00089).

 
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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 Key7572720
MDR Text Key110181241
Report Number3004774118-2018-00088
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number2901-86055YA
Device LOT NumberGHLC
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/19/2018
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: 06/06/2018 Patient Sequence Number: 1
Treatment
101-655100 LOT FFBE; 101-655100 LOT FKKX; 2901-10001 LOTFTFA; 2901-75535G LOT FWPD; 2901-86055YA LOT GHKM
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