MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E5111-07545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two everest xt fenestrated polyaxial screw tabs fractured intra-operatively.The tabs broke while attempting to place a really difficult rod.All broken fragments, and screws were removed.New screws were used, and the procedure was completed successfully without surgical delay, or harm to the patient.This report represents the first of the two screws.
Event or Problem Description
It was reported that two everest xt fenestrated polyaxial screw tabs fractured intra-operatively.The tabs broke while attempting to place a really difficult rod.All broken fragments and screws were removed.New screws were used and the procedure was completed successfully without surgical delay or harm to the patient.This report represents the first of the two screws.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.It was reported that the patient had very steep angle and the tabs broke while trying to insert a difficult rod.Most likely cause of the reported event was difficult angle at which the surgery was being performed.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 7.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10562641
• Report Number: 3004774118-2020-00212
• Device Sequence Number: 14101058
• Product Code: NKB
• UDI-Device Identifier: 10888857212787
• UDI-Public: 10888857212787
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: E5111-07545
• Device Catalogue Number: E5111-07545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1