MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05026-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event where during implantation, a yukon oct polyaxial screw fractured right below the tulip.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.However, a picture of the broken device was received, confirming the screw had fractured immediately below the ball feature of the screw shank.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records were reviewed for this catalog, and no relevant manufacturing issues or similar complaints were identified.Per additional correspondence, the implant was not inserted at a difficult angle.Excess force was not applied, the bone was prepped using 4.5mm tap, and the screw was properly attached to screwdriver.Some additional bone was removed in order to remove the part of broken screw, and no broken fragments were left in patient.As the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: excess torsional force applied to insert the screw/ hard bone quality of patient.Hospital retained device.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X26 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12721718
• Report Number: 3004774118-2021-00334
• Device Sequence Number: 17213906
• Product Code: NKG
• UDI-Device Identifier: 10888857394971
• UDI-Public: 10888857394971
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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: 7601-05026-G1
• Device Catalogue Number: 7601-05026-G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1