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

Model Number	PC1-105530
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	Malfunction
Additional Manufacturer Narrative
The fractured screw head was returned and examined by product engineering.The screw shank was left implanted in the patient.Visual inspection of the screw head did not note any atypical features or damage.The screw head was fractured at the intersection of the neck diameter and the radius leading up to the spherical head.The reporter noted that the patient had sclerotic bone which is significantly denser than average bone.Benchtop testing was performed with 5.5x30mm and 5.5x34mm favored angle screws.The torque required to fracture a 5.5mm screw was measured by clamping the screw shank in a vice and applying torque to the head.Screws were then fully implanted into various densities of bone foam blocks using the same pilot hole preparation indicated in the report.In all cases, the measured implantation torque was less than that required to fracture the screw neck, even on the high-density "sclerotic cortical" bone foam block.No fractures occurred; the reported failure mode could not be replicated.Review of labeling: possible adverse events - bending, disassembly, or fracture of implant and components.
Event or Problem Description
On 13 jul 2023 seaspine became aware that a pc1-105530 poly.Screw, favored angle 5.5mm x 30mm fractured intra-operatively and a portion of the screw remained in the patient.The index surgery took place on (b)(6) 2023.According to the reporter, the surgeon freehand power-drilled with a 4.5mm drill at t1.This was followed with a 4.5mm tap.The bone was noted to be sclerotic and not hard.The surgeon then drove the 5.5x30mm screw with a poly driver (threaded) about ¾ of the way.The screw fractured at the neck when the screw was approximately 4mm proud.The rep noted that the surgeon was not too forceful.The surgeon cleaned up the proud screw shank and left remaining portion in patient.Construct ended at t2.No radiographs were provided.No patient injury was reported and no further information on patient condition was provided.

• Brand Name: NORTHSTAR OCT SPINAL SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad 92008
• MDR Report Key: 17465453
• Report Number: 3012120772-2023-00016
• Device Sequence Number: 2634821
• Product Code: NKG
• UDI-Device Identifier: 10889981197285
• UDI-Public: 10889981197285
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: PC1-105530
• Device Catalogue Number: PC1-105530
• Device Lot Number: CR44697C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown