MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR; NORTHSTAR OCT SET SCREW

Model Number	PC1-400000
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a rod slipped out from underneath a c2 pedicle screw when a patient fell.Xrays taken showed that the set screw wasn't all the way down and appeared cross threaded.Revision surgery was performed on (b)(6) 2022.The initial surgery was on (b)(6) 2022.
Additional Manufacturer Narrative
Failure analysis: the following was returned in this complaint: pc1-003526 screw, lot cr44738b, pc1-400000 set screw, lot cr44667a.The screw was returned in a disassembled state, where the washer, shank, and tulip components were separated.The friction ring remained embedded in the tulip.Measurements of the tulip od and rod channel yielded 9.01mm and 4.25mm, respectively.These values are within spec.These measurements indicate that the tulip has not changed in geometry post-manufacturing.Magnified inspection of implants and components showed wear in multiple locations, but there were no definitive signs of significant damage or change in implant form for all items except for the washer component.Threads appeared intact on both the set screw (pc1-400000) and the tulip (pc1-003500-02-1).The bottom of the set screw showed a wear pattern consistent with locking the set screw on top of a rod with 25 in-lbs of torque, indicating that the set screw was likely fully seated onto a rod.One of the washer's (pc1-003500-04) arm appeared damaged, but this likely occurred during implant removal.The root cause was not identified.The patient's fall may have led to a change in implant performance, but we don't have sufficient information to determine a root cause.

• Brand Name: NORTHSTAR
• Common Device Name: NORTHSTAR OCT SET SCREW
• 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: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13904659
• Report Number: 3012120772-2022-00010
• Device Sequence Number: 19852384
• Product Code: NKG
• UDI-Device Identifier: 10889981198213
• UDI-Public: 10889981198213
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: PC1-400000
• Device Catalogue Number: PC1-400000
• Device Lot Number: CR44687A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PC1-003526 LOT CR44738B
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown