MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 5.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E5111-05540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two everest xt extended tab polyaxial screws at t11 and t12 migrated approximately 1-month post-operatively.The patient has no symptoms but can feel the screws 'sticking into her back'.Revision surgery is not scheduled at this time.This report represents the first of the two screws.
Event or Problem Description
It was reported that two everest xt extended tab polyaxial screws at t11 and t12 migrated approximately 1-month post-operatively.The patient has no symptoms but can feel the screws 'sticking into her back'.Revision surgery is not scheduled at this time.This report represents the first of the two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned, it remains implanted in the patient.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.No further investigation can be performed due to insufficient information provided.  if more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 5.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10814331
• Report Number: 3004774118-2020-00297
• Device Sequence Number: 3526158
• Product Code: NKB
• UDI-Device Identifier: 10888857212411
• UDI-Public: 10888857212411
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: E5111-05540
• Device Catalogue Number: E5111-05540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR