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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 3001-H45500T
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 11/24/2016
Event Type  Injury  
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.Not yet returned.
 
Event Description
On (b)(6) 2016 it was reported to k2m, inc.That a surgery took place in which a fracture rail rod was removed.Revision surgery took place (b)(6) 2016.
 
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.Not yet returned.
 
Event Description
On 11/25/2016 it was reported to k2m, inc.That a surgery took place in which a fracture rail rod was removed.Revision surgery took place (b)(6) 2016.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been 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 11/25/2016 it was reported to k2m, inc.That a surgery took place in which a fractured rail rod was removed.Revision surgery took place (b)(6) 2016.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.An sem analysis of the transition rail showed that it was made of the correct material (titanium alloy).Unfortunately, the fractured faces were so polished, likely from rubbing against each other in the patient, that no conclusions could be drawn as to what type of failure this was (i.E., fatigue, overload, etc.).Microscopic images of the rod's surface, however, revealed abrasions consistent with set screw contact at the location of the fracture.Thus, the rod most likely fractured where the connector's set screw was previously tightened down, as this was a growing rod construct, creating a stress riser in the rod, thereby contributing to the failure.The relatively large span of the unsupported construct (5-6 levels), likely contributed to this failure as well due to increased bending stresses.Our investigation of the product and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.
 
Event Description
On (b)(6) 2016 it was reported to k2m, inc.That a surgery took place in which a fractured rail rod was removed.Revision surgery took place (b)(6) 2016.
 
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Brand Name
MESA SPINAL SYSTEM
Type of Device
PEDICLE 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 Key6201958
MDR Text Key63171090
Report Number3004774118-2016-00105
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857053786
UDI-Public10888857053786
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number3001-H45500T
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/25/2016
Initial Date FDA Received12/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received01/18/2017
02/17/2017
03/15/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
3001-84560G
Patient Outcome(s) Required Intervention;
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