MAUDE Adverse Event Report: K2M, INC. CONSTRAINED PLATE, 4 LEVEL; SIZE 73 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	208-44F73
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pyrenees 4 level constrained plate at c5 fractured four months post-operatively.Revision surgery has not been performed.
Additional Manufacturer Narrative
Corrected data: g1.H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that a pyrenees 4 level constrained plate at c5 fractured four months post-operatively.Revision surgery has not been performed.

• Brand Name: CONSTRAINED PLATE, 4 LEVEL; SIZE 73 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 20896295
• Report Number: 3004774118-2024-00142
• Device Sequence Number: 8773195
• Product Code: KWQ
• UDI-Device Identifier: 10888857031371
• UDI-Public: 10888857031371
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 208-44F73
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/17/2025
• 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 Age: 73 YR
• Patient Sex: Male