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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported via surgeon that a mesa polyaxial screw slipped axially post-operatively.Revision surgery has not been scheduled nor preformed at this time.
Event or Problem Description
It was reported via surgeon that a mesa polyaxial screw slipped axially post-operatively.Revision surgery has not been scheduled nor preformed at this time.
Additional Manufacturer Narrative
Field d6a has been updated with the implant date.Field h10 has been updated with the below summary: visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, post-op x rays were reviewed.There appears to be movement of the left side rod was confirmed via provided imaging, however these x rays were taken at different angles and the amount of movement of the rod cannot be accurately determined.The rod appears to still be captured by the screw.Every other level is fixated alternatively on the construct.The construct ends at the convex curve of the deformity.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.Similar construct design x-rays from the same surgeon for the same failure mode were reviewed by a consultant spine health care provider.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.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, post-op x rays were reviewed.There appears to be movement of the left side rod was confirmed via provided imaging, however these x rays were taken at different angles and the amount of movement of the rod cannot be accurately determined.The rod appears to still be captured by the screw.Every other level is fixated alternatively on the construct.The construct ends at the convex curve of the deformity.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 identiifed.Similar construct design x rays from the same surgeon for the same failure mode were provided and reviewed by a consultant spine hcp.The hcp believes construct design with difficult deformities was the most likely contributing factor to the event.From his analysis, the surgeon used a low density screw construct ending the construct on the convex curve of the deformity.The low screw density, 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 it's original position, causing a failure at the construct's weakest point, the distal most screw on the convex of the deformity curve, leading to the rod slipping from the screw.Additionally, these devices were implanted for over1 year.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.".
Event or Problem Description
It was reported via surgeon that a mesa polyaxial screw slipped axially post-operatively.Revision surgery has not been scheduled nor preformed at this time.

• 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: 14516871
• Report Number: 3004774118-2022-00208
• Device Sequence Number: 5628927
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 08/12/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 09/09/2022; 09/12/2022
• 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