MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04014DA-G1
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that x-ray imaging showed something protruding at the c4 level of an ozark construct.The observed issue may have been due to migrated ozark screws or a fractured locking mechanism of the ozark plate.Additional details regarding this event are unknown at this time.This record captures the first of the two ozark screws.
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that x-ray imaging showed something protruding at the c4 level of an ozark construct.The observed issue may have been due to migrated ozark screws or a fractured locking mechanism of the ozark plate.Additional details regarding this event are unknown at this time.This record captures the first of the two ozark screws.
Additional Manufacturer Narrative
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, no similar complaints were identified.Initial report states that there may be screw migration.X-ray was unable to confirm.It may have been angle of x-ray, the securing mechanism, or screw migration.It was reported that during initial surgery the screws were not implanted at a difficult angle, they were fully seated, no tap was used, patient had normal bone, and patient did not experience a fall.The ozark surgical technique and device ifu were reviewed: ¿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.After screw insertion, engage the locking cover by inserting the size 10 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.¿ no further investigation for this event is possible as no devices or x-rays were received to confirm reported event.Root cause cannot be determined conclusively.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 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: 13014332
• Report Number: 3004774118-2021-00398
• Device Sequence Number: 1817127
• Product Code: KWQ
• UDI-Device Identifier: 10888857408845
• UDI-Public: 10888857408845
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 8801-04014DA-G1
• Device Catalogue Number: 8801-04014DA-G1
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/16/2022
• 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: Male