MAUDE Adverse Event Report: K2M, INC. CONTOURED ROD, BULLETED HEX; SIZE Ø5.5X70 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	1001-E5570
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient underwent a revision surgery approximately three years post-operatively to address a fractured denali mi contoured rod.
Event or Problem Description
A company representative reported that a patient underwent a revision surgery approximately three years post-operatively to address a fractured denali mi contoured rod.
Additional Manufacturer Narrative
H6 coding has been updated to reflect device evaluation and investigation conclusion.

• Brand Name: CONTOURED ROD, BULLETED HEX; SIZE Ø5.5X70 MM, TI
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 17344474
• Report Number: 3004774118-2023-00091
• Device Sequence Number: 20568239
• Product Code: NKB
• UDI-Device Identifier: 10888857002098
• UDI-Public: 10888857002098
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 1001-E5570
• Device Catalogue Number: 1001-E5570
• Device Lot Number: KTNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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 Age: 82 YR
• Patient Sex: Female