MAUDE Adverse Event Report: K2M, INC. PLATE, 3 LEVEL; SIZE 57 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-43F57V
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately 2 months post-operatively, the securing mechanism of an ozark plate failed causing the two ozark screws at c7 to migrate.Revision surgery has not been performed or scheduled.This report captures plate.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analysis could not be performed as the device associated with this record was not returned.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.An x-ray provided by the surgeon confirms that both caudal screws migrated anteriorly and the plate's caudal securing mechanism disengaged.Additionally, the cranial-most cage is anterior to the most anterior surface of c4 vertebral body.As a result, the cranial end of the plate is resting on the cranial cage instead of the anterior surface of the c4 vertebral body.It was also indicated that the bone was not tapped prior to screw insertion and that the caudal screws were likely over-angulated.The ozark surgical technique was reviewed and the following relevant information was identified: remove all osteophytes from the anterior surfaces of the vertebrae to allow the plate to sit flush against the vertebral bodies.The screws are colored-coded by length and function (fixed versus variable).Fixed screws can be inserted ±2º and variable screws can be inserted ±15º, in any direction relative to the neutral angle of the screw hole.Screws are available in self-starting and self-tapping options.Note: do not over angulate screws beyond their indicated limit, doing so could result in the inability to lock the cover.Note: fixed screws have a laser marked line on the head of the screw.Once the screw hole is prepared and the appropriately sized screw is selected, screws can be inserted into the plate using the size 10 tapered driver or the size 10 threaded driver.To use the size 10 threaded driver: the size 10 threaded driver has a threaded distal tip to aid in the retention of the screws during insertion.Attach the proximal end of the threaded driver to the torque limiting handle.Insert the distal end of the threaded driver into the screw head and turn the knob clockwise to engage screw.Note: the threaded driver must be used with the 12 in-lbs torque limiting handle.After screw insertion, engage the locking cover by inserting the size10 tapered driver into the screw cover and rotating clockwise 90° so that the cover retains the screw heads.Screws should sit below the screw cover to ensure that the locking cover is adequately engaged.The most likely cause of the reported event was determined to be over-angulation of the caudal screws.It was reported that the [caudal] screws were likely too angled for a fixed screw.The surgical technique states that fixed screws can be inserted ±2º in any direction relative to the neutral angle of the screw hole.The x-ray provided indicates caudal screw(s) were implanted outside of this limit.Over angulation of screws or failure to fully insert screws can interfere with the ability to lock the securing mechanism.This can result in post-operative securing mechanism disengagement due to excessive pressure applied to securing mechanism from the screw heads.Once the securing mechanism is disengaged, there is nothing to prevent the screws from migrating.Additionally, the ao spine top handle was used with the threaded screw driver.The threaded screw driver must be used with the grey torque limiting handle to prevent driver damage and ensure proper placement of screws.
Event or Problem Description
It was reported that approximately 2 months post-operatively, the securing mechanism of an ozark plate failed causing the two ozark screws at c7 to migrate.Revision surgery has not been performed or scheduled.This report captures plate.

• Brand Name: PLATE, 3 LEVEL; SIZE 57 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 14084597
• Report Number: 3004774118-2022-00139
• Device Sequence Number: 20163014
• Product Code: KWQ
• UDI-Device Identifier: 10888857402003
• UDI-Public: 10888857402003
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: AA01-43F57V
• Device Catalogue Number: AA01-43F57V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 07/12/2022
• 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