MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CANNULATED; SIZE Ø5.5X45 MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	M5111-05545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest polyaxial screw fractured post-operatively.Additional information has not been made available at this time.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
We were provided three possible catalog numbers for the device and will update the record if we receive more information.The catalog number could be m5111-05545, m5111-06545, or m5111-06540.H6: coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW, CANNULATED; SIZE Ø5.5X45 MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 22171367
• Report Number: 3004774118-2025-00099
• Device Sequence Number: 7957659
• Product Code: MNI
• UDI-Device Identifier: 10888857148963
• UDI-Public: 10888857148963
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Catalogue Number: M5111-05545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown