MAUDE Adverse Event Report: CAMBER SPINE TECHNOLOGIES ORTHROS MIS; Thoracolumbosacral pedicle screw system

Model Number	ORM-35C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 a 62 year old male patient had gone through surgery during which two orthors mis rods (orm-35c) were implanted.As per patient description when he was doing dishes while loading/unloading dishwasher, he heard a loud pop in his back.The patient felt some pain and knew something was wrong.Patient made a follow up appointment and was seen in office on (b)(6) 2024 in the morning.Upon x-raying patient it was discovered that both 35mm rods were broken.A revision surgery was scheduled on (b)(6) 2024.During the revision surgery the orthros mis rods were explanted along with the pedicle screw and its respective set screws.New orthros mis rods along with new pedicle screws and set screws were implanted.The patient is no longer feeling pain post surgery.

• Brand Name: ORTHROS MIS
• Common Device Name: Thoracolumbosacral pedicle screw system
• Manufacturer (Section D): CAMBER SPINE TECHNOLOGIES; 501 allendale rd; suite 101; king of prussia PA 19406
• MDR Report Key: 20224647
• Report Number: 3010197239-2024-00001
• Device Sequence Number: 15263898
• Product Code: NKB
• UDI-Device Identifier: B030ORM35C0
• UDI-Public: B030ORM35C0
• Combination Product (Y/N): N
• PMA/510(K) Number: K133366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ORM-35C
• Device Lot Number: BG06222B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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: 63 YR
• Patient Sex: Male