MAUDE Adverse Event Report: K2M, INC. STRAIGHT RAIL; SIZE Ø5.5X495 MM TI, MESA RAIL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-H55495
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mesa deformity straight rail and a denali deformity straight rod broke 18 months post -operatively.Revision will be performed, but has not been scheduled at this time.This report will capture the mesa deformity straight rail.
Additional Manufacturer Narrative
Device remains implanted in patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, x rays were provided showing a fractured rod and rail.Construct was heavily fixated on one side, with the other side having fixation at the top and bottom of the construct with only 2 fixation points in-between 8 levels.Fracture occurred at the apex of the deformity curve on the less fixated side, which allowed for a large bending moment to exist within the non fixated region, which can eventually cause a fatigue breakage of the rod.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no similar complaints were identified.From the pedicle screw systems ifu: internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.The devices were implanted for a period of 18 months with a confirmed non union.The cause of the event is multifactorial with the construct design along with the patient's non union contributing to the event.It is also unknown if the patient fell or what the patient's post op activity level was, which both could have contributed to the event as well.
Event or Problem Description
It was reported that a mesa deformity straight rail and a denali deformity straight rod broke 18 months post -operatively.Revision will be performed, but has not been scheduled at this time.This report will capture the mesa deformity straight rail.

• Brand Name: STRAIGHT RAIL; SIZE Ø5.5X495 MM TI, MESA RAIL
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12941597
• Report Number: 3004774118-2021-00380
• Device Sequence Number: 4616618
• Product Code: NKB
• UDI-Device Identifier: 10888857144248
• UDI-Public: 10888857144248
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 801-H55495
• Device Catalogue Number: 801-H55495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown