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
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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)
• 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: 12824602
• Report Number: 3004774118-2021-00359
• Device Sequence Number: 4335501
• Product Code: NKB
• UDI-Device Identifier: 10888857008946
• UDI-Public: 10888857008946
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K141873
• 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): 03/09/2022

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: 101-85555F
• Device Catalogue Number: 101-85555F
• Device Lot Number: GUUB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• 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