• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

K2M, INC. MESA SM STATURE SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 3001-84545
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 10/20/2017
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 as it remains in the patient's body. Investigation is still in process. When investigation is complete, k2m inc. Will file a supplemental report indicating the findings.

 
Event Description

On (b)(4) 2017 it was reported to k2m, inc. That a failed connector was discovered post-operatively. Revision surgery was performed on (b)(6) 2017.

 
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 rod connector remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained. The set screws used in the index surgery were discarded and replaced. Attempts to recreate the incident indicate that if the set screws are fully tightened when the rods are not parallel to one another, it is possible to generate a point contact between the set screw and the rod. This could have contributed to decreased axial rigidity thus leading to rod slippage.

 
Event Description

On (b)(6) 2017 it was reported to k2m, inc. That a failed rod connector was discovered post-operatively. Revision surgery was performed on (b)(6) 2017 in which additional connectors were added to each side of the construct.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESA SM STATURE 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
5719192195
MDR Report Key7028384
MDR Text Key91935529
Report Number3004774118-2017-00185
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number3001-84545
Device LOT NumberFPMH
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 Received10/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/23/2017
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: 11/14/2017 Patient Sequence Number: 1
-
-