MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of a yukon oct spinal system polyaxial screw broke off of the shank during insertion into the pedicle of t2.The screw was removed and surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that screw had fractured immediately below the ball feature of the screw shank.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Analysis of the fracture face indicated that the failure likely occurred in torsion.The subject screw has a diameter of 05.0x24 mm and requires more torque.Inserting the screw in harder than normal bone can compound torsional forces at the shaft, leading to the failure.
Event or Problem Description
It was reported that the head of a yukon oct spinal system polyaxial screw broke off of the shank during insertion into the pedicle of t2.The screw was removed and surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X24 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10203370
• Report Number: 3004774118-2020-00130
• Device Sequence Number: 1020062
• Product Code: NKG
• UDI-Device Identifier: 10888857349995
• UDI-Public: 10888857349995
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 7601-05024
• Device Catalogue Number: 7601-05024
• Device Lot Number: HFRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1