MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY UNIPLANAR SCREW; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6201-36540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a mesa screw at l1 displaced from a rod post-operatively.Revision surgery has not been scheduled or performed at this time.
Event or Problem Description
It was reported that a mesa screw at l1 displaced from a rod post-operatively.Revision surgery has not been scheduled or performed at this time.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.Initial surgery was performed on (b)(6) 2021.No difficulties were reported during partial or final locking.Patient had normal bone quality and no pathologies.No complications during the initial surgery were reported.It was reported that the rod slipped out of the screw 2 months after surgery.There are no plans for a revision as the patient is currently asymptomatic.A x ray was provided confirming the rod disengaged from the screw post operatively.Operative notes were also provided.A consultant spine health care professional (hcp) reviewed both the x ray and operative notes.From the consultant spine hcp's review of x ray and operative notes: "it looks like the rods were on the short side to begin with, and then slipped a bit.There's nothing in the op note that would be worrisome.I just think their rods were cut a little too short and disarticulated from the screws." the mesa surgical technique and device ifu were reviewed: the mesa surgical technique states that the user needs to confirm at least 5 mm of rod length extends beyond the most proximal and distal screws.For optimum results careful preoperative diagnosis and planning, meticulous surgical technique and extended post operative care by experienced spinal surgeons are essential.Prior to use the surgeon should be specifically trained in the use of this spinal system and the associated instrumentation to facilitate correct selection and placement of the implants.The size and shape of bones and soft tissue place limitations on the size and strength of the implants and proper selection will reduce the risk of neurological injury during implantation as well as metal fatigue leading to bending and breakage of the device.As the devices are currently implanted and unavailable for review, a definite cause cannot be determined.Based on the hcp's review of the x rays and operative notes, the likely cause is there was not enough rod overhang.

• Brand Name: MESA 2 DEFORMITY UNIPLANAR SCREW; SIZE Ø6.5X40 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: 12377607
• Report Number: 3004774118-2021-00262
• Device Sequence Number: 4115650
• Product Code: NKB
• UDI-Device Identifier: 10888857169173
• UDI-Public: 10888857169173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 6201-36540
• Device Catalogue Number: 6201-36540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 01/25/2022
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 72 KG