MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04016CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported post-operatively by x-ray that an ozark self tapping variable screw was fractured.Revision surgery has not been scheduled or performed at this time.
Event or Problem Description
It was reported post-operatively by x-ray that an ozark self tapping variable screw was fractured.Revision surgery has not been scheduled or performed at this time.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.Initial surgery was performed on (b)(6) 2021 and revision surgery has not been performed to date.Pre-op and post-op x-rays were reviewed and the following was noted.2 weeks post-op x-ray shows caudal screws to be at a higher degree of angulation with respect to the plate than cranial screws.Caudal screws may be over angulated and/or not completely seated in the plate.At 2 months post-op, slight subsidence can be noted by the shift (decrease) in caudal screw angulation with respect to the plate.At 6 months post-op, it appears that the interior endplate at c5 may not have fused and that there is possible pseudo at inferior endplate of c6.Additionally, cranial screw fracture is observed at c5.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.¿ device ifu states that "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." since the device was not returned, an exact cause of the reported event could not be determined.Multiple factors may have contributed to reported event.2 weeks post-op x-rays indicate caudal screws may have been over angulated.6 month post-op x-ray shows signs of potential pseudo and/or non-fusion.

• Brand Name: SELF-TAPPING SCREW, CONSTRAINED; SIZE Ø4.0X16 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: 12573531
• Report Number: 3004774118-2021-00300
• Device Sequence Number: 3420488
• Product Code: KWQ
• UDI-Device Identifier: 10888857392878
• UDI-Public: 10888857392878
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8801-04016CA
• Device Catalogue Number: 8801-04016CA
• 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: 10/04/2021
• Supplement Report FDA Received Date: 01/19/2022
• 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 Age: 63 YR
• Patient Sex: Male