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

Model Number	811-H55495
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that the patient is unresponsive in their lower right leg following surgery.During the implantation of a mesa straight rail, the surgeon noted that the, "lower extremity waveform disappeared." imaging was performed and no device problem was seen.The surgeon removed and replaced the rail but the, "lower limb waveform," did not return.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.A consultant hcp reviewed this case and they stated that the "cause is likely from the deformity correction itself, doubt it is coming from the rod.Normally when the surgeon sees a change in monitoring during the surgery, they undo the correction and see if it comes back".The mesa rail deformity surgical technique was reviewed and the following was found to be relevant: potential risks identified with the use of this device system which may require additional surgery include device component failure, loss of fixation, non union, fracture of the vertebra, and neurological, vascular or visceral injury.At this time, there is no indication of a device failure that caused this patient harm.According to analysis from the consultant hcp, the cause is likely from the deformity correction itself and not the rod.
Event or Problem Description
It was reported that the patient is unresponsive in their lower right leg following surgery.During the implantation of a mesa straight rail, the surgeon noted that the, "lower extremity waveform disappeared." imaging was performed and no device problem was seen.The surgeon removed and replaced the rail but the, "lower limb waveform," did not return.

• Brand Name: STRAIGHT RAIL; SIZE Ø5.5X495 MM COCR, 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: 12450926
• Report Number: 3004774118-2021-00273
• Device Sequence Number: 3503746
• Product Code: NKB
• UDI-Device Identifier: 10888857144590
• UDI-Public: 10888857144590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: Health Professional
• Device Model Number: 811-H55495
• Device Catalogue Number: 811-H55495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Unknown