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	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that a rod has slipped down the screwhead of a mesa deformity uniplanar screw.The securing mechanism of the mesa screw is designed to retain the rod and keep it in place.The reported event is attributable to the screw as the rod cannot migrate when properly secured in a accurately locked screwhead.Revision surgery has neither been performed or scheduled.
Event or Problem Description
A physician reported that a rod has slipped down the screwhead of a mesa deformity uniplanar screw.The securing mechanism of the mesa screw is designed to retain the rod and keep it in place.The reported event is attributable to the screw as the rod cannot migrate when properly secured in a accurately locked screwhead.Revision surgery has neither been performed or scheduled.
Additional Manufacturer Narrative
D6a: implant date has been changed.
Event or Problem Description
A physician reported that a rod has slipped down the screwhead of a mesa deformity uniplanar screw.The securing mechanism of the mesa screw is designed to retain the rod and keep it in place.The reported event is attributable to the screw as the rod cannot migrate when properly secured in a accurately locked screwhead.Revision surgery has neither been performed or scheduled.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analyses could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, similar complaints were identified.A surgeon trend was noted for this failure mode for mesa screws.The international marketing team was notified and have set up meetings and discussions with this surgeon.Although the devices remains implanted and can therefore not be analyzed, x-ray imaging was provided by the field.Imaging shows slight movement of the rod axially.Similar construct design x-rays from the same surgeon for the same failure mode were reviewed by a consultant spine health care provider on 23 june 2021.The physician believes that the construct design with difficult deformities was the most likely contributing factor to the event.The operating surgeon used a low density screw construct which ended on the convex curve of the spinal deformity.The low screw density and short length of construct, along with possible loss of correction, may not have been enough to counter the force of the spine trying to revert to its original position.This may have resulted in the eventual failure at the distal most screw (where biomechanical loading is most likely greater) leading to the rod slipping from the screw.Additionally, the construct was implanted in 2017 and has been in place for over four years.From the ifu: "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.".

• 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: 12750873
• Report Number: 3004774118-2021-00349
• Device Sequence Number: 4446328
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 01/27/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/14/2021; 02/25/2022
• 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 Sex: Unknown