MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø7.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 2911-07550

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported that the tulip of an everest polyaxial screw "popped off" during intra-operative screw insertion at s1.There were no adverse consequences to the patient.The procedure was completed successfully with an unknown surgical delay.

Manufacturer Narrative

Additional information was received and b5 was updated.

Event Description

It was reported that the tulip of an everest polyaxial screw "popped off" during intra-operative screw insertion at s1.The screw was removed and replaced.There were no adverse consequences to the patient.The procedure was completed successfully with a 3 minute surgical delay.

Event Description

It was reported that the tulip of an everest polyaxial screw "popped off" during intra-operative screw insertion at s1.The screw was removed and replaced.There were no adverse consequences to the patient.The procedure was completed successfully with a 3 minute surgical delay.

Manufacturer Narrative

A visual inspection was performed on the device which was returned with the shank and tulip disengaged.The ball head of the screw shank was observed to have deformation of the hexalobe pattern, the proximal opening, and the outer circumference.The distal side of the disengaged tulip head was also observed to have damage, with a portion of the anvil component fractured and the housing deformed.Device history records were reviewed for the corresponding lot and no relevant issues were identified.A review of complaint history associated with the subject lot and catalog number was performed, and no adverse trends were observed.It was initially reported that the tulip of an everest polyaxial screw disengaged during screw insertion intra-operatively.The pedicle was prepared properly prior to screw insertion.The patient's bone quality was reported to be good, however, the screw was being inserted at a difficult angle and greater than normal force was applied to the screw driver during implantation.The surgeon was able to remove the screw and retrieve the disengaged tulip.A new screw of the same size was able to be successfully implanted following the removal of the reported device.The everest spinal system degenerative surgical technique (us version) was reviewed: ¿when using an everest polyaxial screw inserter, grasp the implant by the shaft of the screw and apply a downward force to engage the screw into the hexalobe fitting of the screwdriver shaft.Thread the knurled wheel in a clockwise direction until the implant is securely attached to the inserter.To disengage the screw inserter, gently turn the knurled wheel in a counter-clockwise direction, and remove from the surgical field.¿ the most likely root cause for the tulip disengagement can be attributed to the difficult insertion angle and excessive force utilized during implantation.The damages observed on the mating components of the screw shank and tulip indicate that the implant experienced abnormal stresses during insertion into the pedicle.

• Brand Name: POLYAXIAL SCREW; SIZE Ø7.5X50 MM
• 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: 13663316
• MDR Text Key: 286594826
• Report Number: 3004774118-2022-00085
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857042711
• UDI-Public: 10888857042711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2911-07550
• Device Catalogue Number: 2911-07550
• Device Lot Number: PHDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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