MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F40V-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 1 year post-operatively the locking mechanism of an ozark plate fractured and a screw at c7 backed out.Revision surgery has been performed where the devices were explanted and a posterior cervical fusion was performed.This record captures the plate.
Additional Manufacturer Narrative
D6 updated with explant date.
Event or Problem Description
It was reported that approximately 1 year post-operatively the locking mechanism of an ozark plate fractured, and an ozark screw at c7 backed out.Revision surgery was performed to explant the devices and add posterior cervical fixation.This record captures the reported ozark plate.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned / received.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no similar complaints were identified.Initial surgery was on (b)(6) 2020.The patient reportedly has weaker than average bone for their age.There were no complications during initial surgery.Screw holes were prepped with a midas burr, screws were directly implanted following.No tap or drill guide was used.It was reported that the fixed screws may have gone in at too steep of an angle.10 months later, on (b)(6) 2021 it was reported that one of the caudal screws had migrated and the securing mechanism had fractured confirmed by review of x-ray.Most cranial portion of plate is not contacting bone and cranial screw does not have optimal purchase.Pseudo is observed in the c5/6 and c6/7 disc space.Lucency is observed surrounding caudal screws.Additionally, potential fracture in anterior/superior portion of caudal vertebral body may indicate traumatic event.The ozark surgical technique and device ifu were reviewed: "remove all osteophytes from the anterior surfaces of the vertebrae to allow the plate to sit flush against the vertebral bodies.¿ ¿adequately instruct the patient.Postoperative care and the patient¿s ability and willingness to follow instructions are two of the most important aspects of successful healing.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.¿ the most likely cause of the reported event was determined to be multi-factorial.Main contributing factors are the over-angulation of the cranial and caudal screws and patient delayed healing.It was initially reported that the fixed screws were potentially over-angulated.After review of provided x-ray it was confirmed that the cranial screws are over angulated and that the un-migrated caudal screw is over angulated.Over-angulation of screws interferes with the securing mechanism and can cause it to dislocate or fracture.Additionally, cranial screws and plate are not ideally placed and fixed.Plate does not sit completely flush on the bone and cranial screw is not fully fixed in vertebral body.X-ray indicates that patient experienced pseudo in both disc spaces and did not achieve complete fusion after 10 months.Additionally, a potential fracture observed in c7 may indicate patient experience a fall / external trauma.Delayed healing and potential patient trauma can induce excessive stress on the entire construct, which can potentially cause the securing mechanism to fracture.H3 other text: no product returned.
Event or Problem Description
It was reported that approximately 1 year post-operatively the locking mechanism of an ozark plate fractured, and an ozark screw at c7 backed out.Revision surgery was performed to explant the devices and add posterior cervical fixation.This record captures the reported ozark plate.

• Brand Name: PLATE, 2 LEVEL; SIZE 40 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: 12641228
• Report Number: 3004774118-2021-00314
• Device Sequence Number: 19182915
• Product Code: KWQ
• UDI-Device Identifier: 10888857416437
• UDI-Public: 10888857416437
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022

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: AA01-42F40V-G1
• Device Catalogue Number: AA01-42F40V-G1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 12/23/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 12/02/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female