MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	6201-05535
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been requested but will not be returned to stryker.
Event or Problem Description
A physician reported that a patient underwent revision surgery to remove two mesa polyaxial deformity screws which had "backed-out" two weeks after implantation.
Additional Manufacturer Narrative
Correction: updated from 'stryker spine- leesburg' to 'k2m, inc.' visual, dimensional, material, and functional analysis could not be performed as the device was not returned.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.Per mesa 2 surgical technique: screw insertion: mesa 2 deformity polyaxial and mesa 2 deformity uniplanar screws are available to use as the surgeon finds appropriate.To insert the mesa 2 screws, select a handle and inserter.Axial and t-handles are available in both ratcheting and fixed positions.Positions are selected by turning the dial located at the bottom of the handle.Attach the inserter to a handle.After the pedicle screw pathway has been prepared and proper screw size has been determined, load the implant for screw insertion using the mesa 2 screw inserter.It is important to grasp the implant by the screw shaft, while simultaneously applying a force between the screw inserter and implant to properly engage the screw onto the instrument.As the devices and x-rays were unavailable for evaluation, the root cause could not be determined conclusively.Factors that affect the pullout strength of the screw include the diameter of the screw and the length of engagement of the thread.Not using a large enough screw diameter can result in screw pullout.It is also possible the screws were not inserted to the appropriate depth.Screw purchase increases as the depth of insertion increases.Screw pullout can also result if the patient has osteoporotic bone.No further investigation for this event is possible at this time as no device and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
A physician reported that a patient underwent revision surgery to remove two mesa polyaxial deformity screws which had "backed-out" two weeks after implantation.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 5.5X35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9131872
• Report Number: 3004774118-2019-00111
• Device Sequence Number: 16792166
• Product Code: NKB
• UDI-Device Identifier: 10888857163751
• UDI-Public: 10888857163751
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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 Catalogue Number: 6201-05535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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