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U.S. Department of Health and Human Services

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

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K2M, INC. MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 801-08550D
Device Problem Device Issue (2379)
Patient Problem No Information (3190)
Event Date 09/06/2016
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 as it remains in the patient. Investigation is still in process. Upon completion of the investigation, k2m inc. Will file a supplemental report indicating the findings. Remains in patient.

 
Event Description

On 09/08/2016 it was reported to k2m, inc. That during a surgery which took place on (b)(6) 2016 a mesa screw was left in the patient and was not fully locked to the rod.

 
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 screw remains in the patient, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained. It was reported that multiple instruments could not engage and fully lock the screw. It is likely that the lips of outer collet became compromised at some point during the case. Once compromised it becomes difficult for instruments to fully engage onto the screw head. However, without the actual implant no definitive root cause can be determined. Our investigation and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends. Remains in patient.

 
Event Description

On (b)(6) 2016 it was reported to k2m, inc. That during a surgery which took place on (b)(6) 2016 a mesa screw was left in the patient and was not fully locked to the rod.

 
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Brand NameMESA 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 Key6001167
MDR Text Key56542623
Report Number3004774118-2016-00078
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133944
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 09/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number801-08550D
Device LOT NumberDGEF
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 Received09/08/2016
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

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