MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-36545M

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

A company representative reported an axial slip of a mesa deformity uniplanar screw.Revision surgery has not been scheduled.

Manufacturer Narrative

The device was not returned for evaluation.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed for the reported catalog and similar complaints for were identified, originating from the same surgeon.Although post-operative x-rays were provided, the images are taken from different angles and there appears to be no discernable slip.The patient is fixated on alternating levels.Similar construct design x-rays from the same surgeon for the same failure mode were reviewed by a consultant spine health care provider on (b)(6) 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.It cannot be confirmed if an axial slip occurred from the images provided and a root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

Event Description

A company representative reported an axial slip of a mesa deformity uniplanar screw.Revision surgery has not been scheduled.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM
• Type of Device: 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: 14292337
• MDR Text Key: 292725368
• Report Number: 3004774118-2022-00177
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857140301
• UDI-Public: 10888857140301
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1