MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING, VARIABLE SCREW; 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.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, pre-op and post-op xrays were reviewed and the following was noted: at 2 months post-op, there appears to be some degree of subsidence.Angulation of caudal screws appears to be less than immediately post-op, which indicates subsidence.No fracture observed; similar analysis at 3 months post-op.6 month post-op x-ray screw fracture can be observed.1 year post-op x-ray may indicate potential pseudo, however this cannot be confirmed based on x-ray provided.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no similar complaints were identified.Per surgical technique: potential adverse events include, but are not limited to pseudo arthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudo arthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if appropriate), and ruled out preoperatively.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.Loads produced by load bearing and activity levels will impact the longevity of the implant.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.The most likely cause of the reported event was determined to be patient factors.Subsidence observed between 2-6 months post-op most likely induced excess stress on the construct, potentially causing the event of screw fracture to occur.Additionally, potential pseudo may be observed after 1 year of implantation, indicating potential delayed healing, which can induce excessive forces on the implants.
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.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; 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: 12573555
• Report Number: 3004774118-2021-00299
• Device Sequence Number: 11618071
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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: 01/17/2022
• 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: 58 YR
• Patient Sex: Male