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	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that two ozark self-starting screws fractured at c5.The patient will not be revised.This report captures the first of two screws.
Event or Problem Description
A physician reported that two ozark self-starting screws fractured at c5.The patient will not be revised.This report captures the first of two screws.
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 c5-c7, and it was composed of a two (2) level plate, four (4) screws, and a corpectomy cage at c6.Subsidence was noted in c5/c6.Both screws at c5 were observed to be fractured.The cage subsided superiorly and fusion was not observed at the inferior level.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Subsidence of the cage and non-union was noted in the inferior levels.It is likely that the cause of the observed issue was multifactorial.Subsidence and non-union, compounded with dynamic loading, likely contributed to the observed fractures.According to the ozark surgical technique, if healing is delayed or does not occur, the implant could break, bend, or loosen.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: 11400811
• Report Number: 3004774118-2021-00066
• Device Sequence Number: 3381863
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/02/2021
• 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