MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR OCT SPINAL SYSTEM; POLY. SCREW, 4.0MM X 20MM

Model Number	PC1-004020
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect screw was not returned for investigation.Review of the device history record confirmed the implant passed all functional and dimensional testing and was within specification at the time of inspection.The reported washer was not visible in the patient or via x-ray.Furthermore, there was no patient injury or medical intervention required.There was no clinical impact to the patient as a result of the failure reported.Review of labeling possible adverse events: bending, disassembly or fracture of implant and components.
Event or Problem Description
A patient underwent spinal surgery on (b)(6) 2021 consisting of seaspine's northstar oct spinal system.A screw disassembled in-situ while the surgeon was correcting the trajectory.The screw and mating tulip were recovered; however, the tulip washer was left inside the patient.

• Brand Name: NORTHSTAR OCT SPINAL SYSTEM
• Common Device Name: POLY. SCREW, 4.0MM X 20MM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13051246
• Report Number: 3012120772-2021-00091
• Device Sequence Number: 19821308
• Product Code: NKG
• UDI-Device Identifier: 10889981196202
• UDI-Public: 10889981196202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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 Model Number: PC1-004020
• Device Catalogue Number: PC1-004020
• Device Lot Number: CR44684B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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 Sex: Unknown