MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X18 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04018CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that two ozark screws at c7 fractured approximately 3 months post-operatively.An unknown cage has also migrated anteriorly.Revision surgery will not be performed.This report captures the second of two screws.
Additional Manufacturer Narrative
Remains implanted in the patient.
Additional Manufacturer Narrative
B5, cage, was corrected from "unknown cage" to "cascadia cervical cage" following additional information.Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.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, and no adverse trends were observed.The reported event of an ozark self tapping variable screw fracturing post-operatively was confirmed via communication with the field and x-ray review.The post-event x-ray review confirms both caudal screws fractured and that the c6/7 cage is pushing out anteriorly.Construct is a 3 level ozark plate from c4 - c7 with 3 cages.Review of x-ray with r&d confirms that the cages in the x-ray are consistent with stryker cascadia cervical cages.Degree of cage migration cannot be confirmed because no immediate post-op x-ray was provided and because no additional x-rays were provided, it could not be confirmed if the cage migration or screw fractures occurred first.Additionally, it was reported via follow up communication that there is no plan to revise the patient and no patient pain was reported.There were no complications during the initial procedure.Screws were inserted using the tapered driver.There was no difficulty locking the securing mechanism.The patient did not experience a fall/accident post-op.It is unknown what the patient¿s activity level was post-op and no immediate post-op x-rays were provided.The most likely root cause of the reported event is deviation from the instructions for use.Cascadia cervical cages are indicated for use in one to two contiguous levels; in this event, cascadia cervical cages were utilized in three contiguous levels.This deviation from the ifu likely contributed to the cage migration and led to additional stresses on the construct, resulting in the fracture of the ozark screws at the caudal level.
Event or Problem Description
A company representative reported that two ozark screws at c7 fractured approximately 3 months post-operatively.A cascadia cervical cage has also migrated anteriorly.Revision surgery will not be performed.This report captures the second of two screws.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X18 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: 14875869
• Report Number: 3004774118-2022-00255
• Device Sequence Number: 5631437
• Product Code: KWQ
• UDI-Device Identifier: 10888857392892
• UDI-Public: 10888857392892
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 09/14/2022

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: 8801-04018CA
• Device Catalogue Number: 8801-04018CA
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/14/2022
• 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