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

Model Number	8801-04014CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	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 the patient.
Event or Problem Description
It was reported that an ozark self-tapping variable screw fractured post-operatively.Upon review of provided imaging, two ozark self-tapping variable screw appear to be fractured.Revision surgery has not been performed at this time.This record captures the first of the two reported ozark self-tapping variable screws.
Event or Problem Description
It was reported that an ozark self-tapping variable screw fractured post-operatively.Upon review of provided imaging, two ozark self-tapping variable screw appear to be fractured.Revision surgery has not been performed at this time.This record captures the first 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 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) 2020 and revision surgery has not been performed to date.No complications during the initial surgery were reported.The bone was not tapped, the all in one guide was not used, the screws were inserted using a regular screwdriver and the angle of insertion was not excessive.Patient's bone quality was reported to be normal.Pre-op and post-op x-rays were reviewed and the following was noted.3 month post-op x-ray does not reveal any screw fracture, there are potential indications of pseudo.9 month post-op x-ray reveals screw fractures.Additionally, the vertebral body associated with the caudal screws has a fracture through the body not observed in 3 month post-op x-ray indicating a potential trauma event.Bone graft is not consolidated and pseudo has most likely occurred.The ozark surgical technique and device ifu were reviewed: "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.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 patient factors and/or a potential traumatic event.No screw fracture was observed before 3 months post-op.Vertebral fracture observed in 9 month post-op x-ray is directly in line with caudal screw fractures.Additionally, potential pseudo may be observed after 9 months of implantation, indicating potential delayed healing, which can induce excessive forces on the implants.

• Brand Name: SELF-TAPPING, 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: 12593065
• Report Number: 3004774118-2021-00306
• Device Sequence Number: 3289341
• Product Code: KWQ
• UDI-Device Identifier: 10888857392854
• UDI-Public: 10888857392854
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 8801-04014CA
• Device Catalogue Number: 8801-04014CA
• 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: 10/07/2021
• 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: 55 YR
• Patient Sex: Female