MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 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	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
It was reported that a rod slipped through the screwhead of a mesa uniplanar screw post-operatively.Revision surgery is now needed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was reported the rod slipped out of the screw 9 months after implantation.The patient was an adolescent neuromuscular case with unknown post-op activity.X-rays were provided and reviewed by an hcp on (b)(6) 2021.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, resulting in the eventual failure at the distal most screw where biomechanical loading is most likely the highest, leading to the rod slipping from the screw.
Event or Problem Description
It was reported that a rod slipped through the screwhead of a mesa uniplanar screw post-operatively.Revision surgery is now needed.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11740927
• Report Number: 3004774118-2021-00123
• Device Sequence Number: 14312343
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention