MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-05545
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devices remains implanted.
Event or Problem Description
It was reported that during intra-operative final tightening of an everest polyaxial screw at t5, the screw tulip 'splayed'.The screw was left inside the patient as is.There were no adverse consequences to the patient.The procedure was completed successfully with a 1-minute delay to surgery by leaving the screw in place.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per email correspondence, tulip was not over angulated.Final tightening was performed using torque wrench and anti torque handle, excessive force was not applied.Due to device not returned, an exact cause of the reported event could not be determined.Causes related to this event include: excess torque applied while final tightening, torque wrench not calibrated, cantilever force applied, etc.
Event or Problem Description
It was reported that during intra-operative final tightening of an everest polyaxial screw at t5, the screw tulip 'splayed'.The screw was left inside the patient as is.There were no adverse consequences to the patient.The procedure was completed successfully with a 1-minute delay to surgery by leaving the screw in place.

• Brand Name: POLYAXIAL SCREW; SIZE 5.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11023570
• Report Number: 3004774118-2020-00349
• Device Sequence Number: 3617709
• Product Code: NKB
• UDI-Device Identifier: 10888857041912
• UDI-Public: 10888857041912
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 2911-05545
• Device Catalogue Number: 2911-05545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1