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

Model Number	8801-14018CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that two ozark self-tapping variable screws fractured post-operatively.This event was noticed upon the patient's follow up x-ray.Revision surgery has not been performed nor scheduled at this time.This record captures the second of the two reported ozark self-tapping variable screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.The provided x-ray confirmed that the securing mechanism of the ozark plate is fractured off from its intended location.Additionally, it was observed that the most caudal screws fractured approximately half way down the shank.The cranial screw head can be observed on anterior side of the plate indicating cranial screw(s) may potentially be over angulated.Over angulation of screws can interfere with the locking of the securing mechanism and compromise the structural integrity of the system.Correspondence with the field representative suggests that a single drill guide was used with a 16mm drill , and no tap was used.Device history records and complaint history could not be reviewed as the device lot number was not available.Complaint history was reviewed for the corresponding catalog number, and no adverse trends were observed.The ozark view and guide 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.Bending at or near the screw holes may damage the integrated alloy locking cover.Therefore, bending should only occur in one direction (lordosis or kyphosis)within the desired bend zone area around each window, pictured below.There may be limited or no-bend zones on the shorter plates.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; if tapping is required, the 10 mm tap may be inserted into the previously drilled screw holes to tap the vertebral bodies.The depth of the tap within the vertebral body will be restricted to up to 10 mm below the plate.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.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 note: plate geometry should prevent the locking cover from rotating beyond the intended 90°.Do not rotate the locking cover past the clockwise stop on the plate.As the devices were not returned and immediate post-op x-rays were not available, a definitive root cause could not be determined.Potential root causes include, over angulation of screws, external trauma, patient fall, improper placement of implants, pseudoarthrosis, and/or subsidence.
Event or Problem Description
It was reported that two ozark self-tapping variable screws fractured post-operatively.This event was noticed upon the patient's follow up x-ray.Revision surgery has not been performed nor scheduled at this time.This record captures the second of the two reported ozark self-tapping variable screws.

• Brand Name: FIXED SCREW, SELF-TAPPING; 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: 12586938
• Report Number: 3004774118-2021-00305
• Device Sequence Number: 1205326
• Product Code: KWQ
• UDI-Device Identifier: 10888857391871
• UDI-Public: 10888857391871
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 8801-14018CA
• Device Catalogue Number: 8801-14018CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/28/2021
• 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 Age: 63 YR
• Patient Sex: Female