MAUDE Adverse Event Report: K2M, INC. FIXED SCREW, SELF-STARTING; SIZE 4.0X20 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-14020DA
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.
Event or Problem Description
It was reported that an ozark view fixed screw implanted at c5 broke one year post-operatively.The patient has fused and there are no plans for revision.
Event or Problem Description
It was reported that an ozark view fixed screw implanted at c5 broke one year post-operatively.The patient has fused and there are no plans for revision.
Additional Manufacturer Narrative
Visual inspection: the issue was confirmed through inspection of the associated imaging in a meeting with the surgeon.The construct spanned from c3-c5, and it was composed of a two (2) level plate, six (6) screws, and interbodies.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.One screw fracture occurred at the caudal-most level of the construct (c5).It was reported that the patient had fused; however, subsidence was noted.Subsidence, compounded with dynamic loading after healing, likely contributed to the observed fracture.According to the ozark surgical technique, implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.The cause of the reported event will be classified as 'patient factors issue'.

• Brand Name: FIXED SCREW, SELF-STARTING; SIZE 4.0X20 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11335424
• Report Number: 3004774118-2021-00046
• Device Sequence Number: 19511333
• Product Code: KWQ
• UDI-Device Identifier: 10888857392403
• UDI-Public: 10888857392403
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 8801-14020DA
• Device Catalogue Number: 8801-14020DA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1