MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING, VARIABLE SCREW; SIZE 4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04016CA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two ozark variable screws at c6 fractured approximately 3 months post-operatively.Revision surgery has not been performed or scheduled at this time.Fusion was not achieved.This report represents the first of the two screws.
Event or Problem Description
It was reported that two ozark variable screws at c6 fractured approximately 3 months post-operatively.Revision surgery has not been performed or scheduled at this time.Fusion was not achieved.This report represents the first of the two screws.
Additional Manufacturer Narrative
Visual inspection: the issue was confirmed through inspection of the associated radiographic image.Both screws at the caudal-most level of the construct appear to have been fractured at c6.The construct spanned from c3-c6, and it was composed of a three (3) level plate, eight (8) screws, and three (3) interbodies.Fusion was not achieved.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Incidences of this nature can be multifactorial.As fusion could not be confirmed in the provided radiographic image, it is possible that pseudoarthrosis could have contributed to the event.According to the ozark surgical technique, if healing is delayed or does not occur, the implant could break, bend, or loosen.In addition to pseudoarthrosis, the integrity of the construct could have also been influenced by the number of levels instrumented.The use of a larger construct could have created an increase of dynamic loading at the caudal levels, contributing to the observed fractures.As the reported devices remain implanted in the patient, the cause of the reported event could not be established conclusively.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; SIZE 4.0X16 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11309564
• Report Number: 3004774118-2021-00038
• Device Sequence Number: 14419320
• Product Code: KWQ
• UDI-Device Identifier: 10888857392878
• UDI-Public: 10888857392878
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/28/2021

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: 8801-04016CA
• Device Catalogue Number: 8801-04016CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR