MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø6.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a planned revision surgery to proximally extend the construct, the tulip of the left proximal screw at l2 had partially disengaged from the screw shaft post-operatively.Subsequently, this caused a loosening of the proximal screws and mild scoliosis.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog number, no adverse trends were observed.The patient underwent l2-s1 arthrodesis surgery in early 2021.The patient had previously undergone spine surgery (l4-s1) at another facility.For clinical reasons it was decided to perform the revision of the instrumentation with proximal extension.The mesa instrumentation was chosen as it was the same as the one already implanted.An x ray provided shows rod slippage from the left l2 screw.It was reported that the rod was still inside the tulip but since it was not gripping it completely, it caused the rod to slip.It was reported that standard technique for placement of screws and rods was used and the supplied instruments were used.The ifu states: "internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant." as the devices were not returned, a definite cause cannot be determined.The devices were implanted for almost a year, loads produced by load bearing and activity levels will impact the longevity of the implant, and may cause it to loosen.It also cannot be determined from the pictures provided if the left l2 screw was fully locked.
Event or Problem Description
It was reported that during a planned revision surgery to proximally extend the construct, the tulip of the left proximal screw at l2 had partially disengaged from the screw shaft post-operatively.Subsequently, this caused a loosening of the proximal screws and mild scoliosis.

• Brand Name: POLYAXIAL SCREW; SIZE Ø6.5X50 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: 13790999
• Report Number: 3004774118-2022-00109
• Device Sequence Number: 17119974
• Product Code: NKB
• UDI-Device Identifier: 10888857136212
• UDI-Public: 10888857136212
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 801-06550
• Device Catalogue Number: 801-06550
• Device Lot Number: JKEH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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