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

Model Number 811-H55495

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Paralysis (1997)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 270787764
• Report Number: 3004774118-2021-00273
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857144590
• UDI-Public: 10888857144590
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR