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	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported that two ozark self-tapping screws at the bottom of a 4-level ozark plate were found to be fractured during the patient's scheduled, 3-month follow-up visit.The patient is reported to have fused and revision is not planned.This report represents the second of the two screws.
Event or Problem Description
A physician reported that two ozark self-tapping screws at the bottom of a 4-level ozark plate were found to be fractured during the patient's scheduled, 3-month follow-up visit.The patient is reported to have fused and revision is not planned.This report represents the second 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.The construct was composed of a four (4) level plate, ten (10) screws, and bone graft.Functional, dimensional, and material analysis were unable to be performed as the device was not available for evaluation.Review of the complaint and device history records could not be performed as a valid lot code was not identified.It is not clear what may have caused the screws to fracture, but it is possible that factors such as pseudoarthrosis contributed to the issue.Although it was reported that the patient was fused, it is possible that the screws were broken prior to fusion being achieved.Ultimately, this potential failure mode could not be properly evaluated, and no cause could be determined based on the available information.

• 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: 10884871
• Report Number: 3004774118-2020-00319
• Device Sequence Number: 3005375
• 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): 01/21/2021

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: No Information
• 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: 10/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1