MAUDE Adverse Event Report: K2M, INC. SACROILIAC SCREW; SIZE Ø9.5X100 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-095100
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported via x-ray that two (2) everest sacroiliac screws showed apparent back out and disengagement post-operatively.The x-ray provided also shows migration of two (2) associated everest set screws.Revision surgery has not been performed or scheduled at this time.This report captures the second of the two everest sacroiliac screws.
Event or Problem Description
It was reported via x-ray that (b)(4) everest sacroiliac screws showed apparent back out and disengagement post-operatively.The x-ray provided also shows migration of (b)(4) associated everest set screws.Revision surgery has not been performed or scheduled at this time.This report captures the second of the two everest sacroiliac screws.
Additional Manufacturer Narrative
Coding has been updated to reflect investigation conclusion.H3 other text : device remains implanted.

• Brand Name: SACROILIAC SCREW; SIZE Ø9.5X100 MM
• Common Device Name: 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: 15258525
• Report Number: 3004774118-2022-00325
• Device Sequence Number: 12430259
• Product Code: NKB
• UDI-Device Identifier: 10888857043275
• UDI-Public: 10888857043275
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133944
• 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): 11/10/2022

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: 2911-095100
• Device Catalogue Number: 2911-095100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown