MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
It was reported that a yukon oct spinal system polyaxial screw fractured intra-operatively.Surgery was successfully completed with a 30-minute surgical delay.
Event or Problem Description
It was reported that a yukon oct spinal system polyaxial screw fractured intra-operatively.Surgery was successfully completed with a 30-minute surgical delay.
Additional Manufacturer Narrative
Visual, functional, dimensional, and material analysis were unable to be performed since the device was not available for investigation.A review of the device and complaint history records could not be performed as a valid lot code was not identified.Based on the available information, it appears that the screw head may have fractured off from the screw shank due to excessive torsional and/or cantilever-bending forces.Ultimately, however, these potential failure modes could not be properly evaluated since the implant was not able to be inspected.As a result, the alleged failure mode could not be confirmed, and no root cause for the issue was able to be determined.

• Brand Name: POLYAXIAL SCREW; SIZE 4.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9960332
• Report Number: 3004774118-2020-00068
• Device Sequence Number: 11467496
• Product Code: NKG
• UDI-Device Identifier: 10888857349605
• UDI-Public: 10888857349605
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: Health Professional
• Device Model Number: 7601-04030
• Device Catalogue Number: 7601-04030
• Device Lot Number: TBC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1