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

Model Number	8801-14016DA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two ozark fixed screws at c6 fractured approximately 6 months post-operatively.Revision surgery has not been scheduled nor performed at this time.This report captures the second of the two ozark screws.
Additional Manufacturer Narrative
G3 (reportability awareness date) has been corrected to '2/08/2020' following additional information received.
Event or Problem Description
It was reported that two ozark fixed screws at c6 fractured approximately 6 months post-operatively.Revision surgery has not been scheduled nor performed at this time.This report captures the second of the two ozark 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 c4-c6, and it was composed of a two (2) level plate, four (4) screws, and a corpectomy cage at c5.Subsidence and non-union was noted in c5/c6.Both screws at the caudal-most level of the construct fractured at c6.Device and complaint history records could not be reviewed for this lot as a valid lot code was not identified.However, no adverse trends were observed for the corresponding catalog number.Ozark view and guide surgical technique was reviewed and the following relevant information was identified: 'internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant'.It is likely that the cause of the observed issue was multifactorial.Subsidence and non-union at that level, compounded with dynamic loading, likely contributed to the observed fractures.The cause of the reported event will be classified as 'patient factors issue'.
Event or Problem Description
It was reported that two ozark fixed screws at c6 fractured approximately 6 months post-operatively.Revision surgery has not been scheduled nor performed at this time.This report captures the second of the two ozark screws.

• Brand Name: FIXED SCREW, SELF-STARTING; 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: 11340004
• Report Number: 3004774118-2021-00051
• Device Sequence Number: 4759992
• Product Code: KWQ
• UDI-Device Identifier: 10888857392366
• UDI-Public: 10888857392366
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: No Information
• Device Model Number: 8801-14016DA
• Device Catalogue Number: 8801-14016DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 02/08/2021; 04/30/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 02/23/2021; 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1