MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was confirmed via x-ray that a mesa small stature deformity screw tulip disengaged post-operatively.It is unknown if the patient will be revised.

Manufacturer Narrative

Visual, dimensional and functional analysis could not be performed as the device was not returned but the x-ray provided shows the tulip of the mesa screw completely disengaged from the threaded shaft.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.A revision surgery did not occur and is not planned.The mesa surgical technique was reviewed and the following relevant information was identified: attach a handle to the mesa polyaxial screw inserter.Ratcheting handles are available in both pear and t-handle styles.The ratchet mechanism is selected by turning the metal portion of the handle to the left or right to engage forward and reverse positions or in the neutral position to fix the ratchet.After the pedicle screw pathway has been prepared and proper screw length and diameter have been determined, the appropriate implant is selected and loaded for screw insertion using the mesa screw inserter.It is important to grasp the implant by the screw shaft while simultaneously applying an upward force to engage the screw onto the screwdriver shaft.A root cause cannot be determined as there is not enough information provided to determine one.Possible root causes include excessive patient post op activity, patient non fusion, excess torque applied to the blockers during final tightening, poor fixation construct, improper screw hole prep, improper screw insertion, and/or poor bone quality.

Event Description

It was confirmed via x-ray that a mesa small stature deformity screw tulip disengaged post-operatively.It is unknown if the patient will be revised.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9356099
• MDR Text Key: 178356009
• Report Number: 3004774118-2019-00144
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1