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

Model Number	E5111-05545
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that an everest xt extended tab polyaxial screw migrated at t10 on the right side post-operatively.Revision surgery is not scheduled at this time as the patient is not showing any symptoms.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog number, and no relevant similar complaints were identified.  due to a lack of information and the device not being returned, the root cause of the reported event can not be determined.Potential root causes include: user error (unstable construct); incorrect or small-sized screws implanted; poor bone quality of patient; patient experiences a fall or trauma post-surgery; high activity level of patient post-surgery.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that an everest xt extended tab polyaxial screw migrated at t10 on the right side post-operatively.Revision surgery is not scheduled at this time as the patient is not showing any symptoms.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; 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: 10824425
• Report Number: 3004774118-2020-00301
• Device Sequence Number: 17063882
• Product Code: NKB
• UDI-Device Identifier: 10888857212428
• UDI-Public: 10888857212428
• 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): 03/26/2021

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: E5111-05545
• Device Catalogue Number: E5111-05545
• 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: 11/11/2020
• 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
• Patient Age: 78 YR