MAUDE Adverse Event Report: K2M, INC. CONTOURED ROD; SIZE Ø5.5X45 MM, TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	101-65545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being submitted retrospectively per fda request.Report was initially reported as 3004774118-2018-00134.It was reported that a patient presented with rod slipped out of a polyaxial screw approximately 3 months post-operatively.Revision surgery took place.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.

• Brand Name: CONTOURED ROD; SIZE Ø5.5X45 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 karen ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7805264
• Report Number: 3004774118-2018-00134
• Device Sequence Number: 6534207
• Product Code: NKB
• UDI-Device Identifier: 10888857006720
• UDI-Public: 10888857006720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• 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): 05/22/2023

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: 101-65545
• Device Catalogue Number: 101-65545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 08/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown