MAUDE Adverse Event Report: K2M, INC. SCREW; SIZE Ø5.5X30 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2001-15530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a chesapeake screw fractured approximately 2 years after implantation.The patient reported experiencing pain and showed signs of pseudo arthrosis.Revision surgery has not taken place nor been scheduled.
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Event or Problem Description
A company representative reported that a patient was revised to address a fractured chesapeake screw approximately 2 years after implantation.The patient reported experiencing pain and showed signs of pseudo arthrosis.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion h3 other text : device location unknown.

• Brand Name: SCREW; SIZE Ø5.5X30 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 17097525
• Report Number: 3004774118-2023-00067
• Device Sequence Number: 19329978
• Product Code: OVD
• UDI-Device Identifier: 10888857025424
• UDI-Public: 10888857025424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2001-15530
• Device Catalogue Number: 2001-15530
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female