MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-36545M
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A company representative reported axial slippage of a mesa deformity screw approximately 26 months post-operatively.Revision surgery is not required.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported axial slippage of a mesa deformity screw approximately 26 months post-operatively.Revision surgery is not required.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 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: 16072711
• Report Number: 3004774118-2022-00424
• Device Sequence Number: 20402009
• Product Code: NKB
• UDI-Device Identifier: 10888857140301
• UDI-Public: 10888857140301
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 801-36545M
• Device Catalogue Number: 801-36545M
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 04/12/2023
• 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