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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital retained implant.
Event or Problem Description
It was reported by a company representative that a yukon screw broke intra-operatively during insertion at t2.No surgical delay nor adverse consequences were reported.The procedure was completed successfully.
Additional Manufacturer Narrative
The reported device was not returned, so an inspection could not be performed.Device history records and complaint history could not be reviewed as the lot number was not provided.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.An exact cause of the reported event could not be determined based on the available information.Potential causes include: bone quality, excess cantilever force applied during insertion, difficult angle, etc.
Event or Problem Description
It was reported by a company representative that a yukon screw broke intra-operatively during insertion at t2.The procedure was completed successfully without surgical delay.No adverse consequences were reported.

• 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: 11941613
• Report Number: 3004774118-2021-00161
• Device Sequence Number: 4226357
• Product Code: NKG
• UDI-Device Identifier: 10888857349803
• UDI-Public: 10888857349803
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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: 7601-04528
• Device Catalogue Number: 7601-04528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1