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

Catalog Number	3001-H45500T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: MESA SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6201958
• Report Number: 3004774118-2016-00105
• Device Sequence Number: 10951668
• Product Code: NKB
• UDI-Device Identifier: 10888857053786
• UDI-Public: 10888857053786
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Catalogue Number: 3001-H45500T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 01/18/2017; 02/17/2017; 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3001-84560G
• Outcome Attributed to Adverse Event: Required Intervention