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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was initially implanted t2 through l1.Approximately two years later the patient was revised to address pseudoarthrosis.The rods were cut at approximately the level of t11, rod-to-rod connectors were placed on the cut ends of the rods, the right-side screw at t11 was removed, a new right-side screw at t12 was implanted, and short rods were placed at the distal end of the construct to maintain the original length of t2 to l1.The x-rays provided by the hospital indicate that the right-side screws at t12 and l1 and the left-side screw at l1 were not replaced but were re-secured.An x-ray provided for three months after surgery appears to show the right-side l3 screw fractured.Six months later, the patient was revised to treat persistent pseudoarthrosis and the construct was extended down to l3.Additionally, the screw fragment at right-side l3 appears to have been removed.An x-ray taken four days after surgery shows a fractured screw shaft in the left-side l1, however, the screw at l1 is intact so the fractured shaft likely belongs to the previously implanted screw.This report captures the right-side mesa deformity uniplanar screw.
Additional Manufacturer Narrative
Device location is unknown.
Event or Problem Description
The patient was initially implanted t2 through l1.Approximately two years later the patient was revised to address pseudoarthrosis.The rods were cut at approximately the level of t11, rod-to-rod connectors were placed on the cut ends of the rods, the right-side screw at t11 was removed, a new right-side screw at t12 was implanted, and short rods were placed at the distal end of the construct to maintain the original length of t2 to l1.The x-rays provided by the hospital indicate that the right-side screws at t12 and l1 and the left-side screw at l1 were not replaced but were re-secured.An x-ray provided for three months after surgery appears to show the right-side l3 screw fractured.Six months later, the patient was revised to treat persistent pseudoarthrosis and the construct was extended down to l3.Additionally, the screw fragment at right-side l3 appears to have been removed.An x-ray taken four days after surgery shows a fractured screw shaft in the left-side l1, however, the screw at l1 is intact so the fractured shaft likely belongs to the previously implanted screw.This report captures the right-side mesa deformity uniplanar screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• 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: 15108328
• Report Number: 3004774118-2022-00283
• Device Sequence Number: 5438386
• 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: 2018
• Device Explanted 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): 10/21/2022

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: 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: 06/28/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/21/2022
• 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
• Patient Age: 14 YR
• Patient Sex: Female