MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.0X20 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04020
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	04/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yukon oct polyaxial screw fractured inta-operatively.There were no adverse consequences to the patient.The procedure was completed successfully, but with an unknown surgical delay.
Additional Manufacturer Narrative
Visual inspection: it was observed that the screw shank was attached to the screw removal tool upon receipt.The screw was fractured immediately below the proximal ball feature of the screw shank, and the threads exhibited significant deformations.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Analysis of the fracture face suggests the failure occurred in torsion.Excessive torque during screw removal may have exceeded the structural integrity of the screw, resulting in fracture.
Event or Problem Description
It was reported that a yukon oct polyaxial screw fractured inta-operatively.There were no adverse consequences to the patient.The procedure was completed successfully, but with an unknown surgical delay.

• Brand Name: POLYAXIAL SCREW; SIZE 4.0X20 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10031259
• Report Number: 3004774118-2020-00082
• Device Sequence Number: 3881757
• Product Code: NKG
• UDI-Device Identifier: 10888857349551
• UDI-Public: 10888857349551
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 09/23/2020

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: 7601-04020
• Device Catalogue Number: 7601-04020
• Device Lot Number: KCNE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1