MAUDE Adverse Event Report: K2M, INC. ROD CONNECTOR, CLOSED/OPEN, WIDE; SIZE Ø5.5 MM (WEDDING BAND); THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 101-85555F

Device Problems Unintended Movement (3026); Migration (4003)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported that the denali rod connector was discovered to be loose during a revision procedure.The procedure was completed successfully.No adverse consequences nor medical intervention were reported.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.No additional information was provided about the event.Dates of the initial and re-spondylodesis surgeries and unknown.Post-op activity and fusion level is unknown.The root cause of the reported event cannot be determined concussively from the information provided and without device evaluation.Potential causes include: - excessive patient post-op activities beyond surgeon recommendation.- patient non-fusion.- poor fixation construct.- device used beyond intended us.

Event Description

It was reported that the denali rod connector was discovered to be loose during a revision procedure.The procedure was completed successfully.No adverse consequences nor medical intervention were reported.

• Brand Name: ROD CONNECTOR, CLOSED/OPEN, WIDE; SIZE Ø5.5 MM (WEDDING BAND)
• 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: 12824602
• MDR Text Key: 280938845
• Report Number: 3004774118-2021-00359
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857008946
• UDI-Public: 10888857008946
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K141873
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-85555F
• Device Catalogue Number: 101-85555F
• Device Lot Number: GUUB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• 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