MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.5X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04528
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yukon oct polyaxial screw fractured intra-operatively.The screw shank broke underneath the tulip head while the surgeon was inserting the yukon screw into the pre-tapped pedicle at t1.The shaft of the screw was left in the patient and the event resulted in a 10-15 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection: it was observed that the screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face indicated that the failure likely occurred in torsion.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, and one similar complaint was identified.According to the rep, the patient's bone quality was hard.The surgeon skipped the subject level, and the surgery was completed successfully.Inserting the screw in harder than normal bone may have compounded torsional forces, resulting in fracture.
Event or Problem Description
It was reported that a yukon oct polyaxial screw fractured intra-operatively.The screw shank broke underneath the tulip head while the surgeon was inserting the yukon screw into the pre-tapped pedicle at t1.The shaft of the screw was left in the patient and the event resulted in a 10-15 minute surgical delay.

• Brand Name: POLYAXIAL SCREW; SIZE 4.5X28 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10391876
• Report Number: 3004774118-2020-00167
• Device Sequence Number: 2898733
• Product Code: NKG
• UDI-Device Identifier: 10888857349803
• UDI-Public: 10888857349803
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/18/2020

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: 7601-04528
• Device Catalogue Number: 7601-04528
• Device Lot Number: KCKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 91