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	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported axial slippage at the distal end of a construct on both the right and left-side.The left-side l3 mesa deformity uniplanar screw shaft additionally appears to be either fractured or disengaged from the tulip.The patient is being revised to address the axial slippage.This report captures the right-side mesa deformity uniplanar screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device not returned.
Event or Problem Description
A physician reported axial slippage at the distal end of a construct on both the right and left-side.The left-side l3 mesa deformity uniplanar screw shaft additionally appears to be either fractured or disengaged from the tulip.The patient is being revised to address the axial slippage.This report captures the right-side mesa deformity uniplanar screw.

• 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: 15108536
• Report Number: 3004774118-2022-00286
• Device Sequence Number: 20190616
• 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
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female