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	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported two fractured ozark screws at the c7 level approximately one year after implantation.Revision status is not currently known.
Event or Problem Description
A physician reported two fractured ozark screws at the c7 level approximately one year after implantation.Revision status is not currently known.
Additional Manufacturer Narrative
Visual inspection: screw fracture was confirmed through inspection of the associated radiographic image.The image showed that the construct was composed of a two (2) level plate, six (6) screws, and two (2) interbodies.Both screws at the caudal-most level of the construct appear to have been fractured.Functional, dimensional, and material analysis could not be performed as the device was unavailable.Review of the device history record and complaint history could not be performed as a valid lot code was not identified.It is not clear what caused the screws to fracture, although it is possible that factors such as pseudoarthrosis contributed to the issue.If arthrodesis of the spine is not achieved then the construct may eventually fail.Ultimately, no cause for the issue could be determined based on the available information.H3 other text : device remains implanted.

• 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: 10642465
• Report Number: 3004774118-2020-00224
• Device Sequence Number: 2439420
• Product Code: KWQ
• UDI-Device Identifier: 10888857392878
• UDI-Public: 10888857392878
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 09/10/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1