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

Model Number 2911-095100

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event 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 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.

Manufacturer Narrative

Coding has been updated to reflect investigation conclusion.H3 other text : device remains implanted.

• Brand Name: SACROILIAC SCREW; SIZE Ø9.5X100 MM
• Type of Device: 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
• MDR Text Key: 300319088
• Report Number: 3004774118-2022-00325
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857043275
• UDI-Public: 10888857043275
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1