MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR POLYAXIAL SCREW, FAVORED ANGLE

Model Number	PC1-105534
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 , a patient underwent spinal surgery utilizing seaspine's northstar posterior cervical fusion system.A favored angle screw broke just below the screw head during insertion into the left side of the t1 vertebrae.A second favored angle screw broke at the same point during insertion into the right side of the t1 vertebrae.Both screw shafts were removed from the patient.This resulted in a 20 to 30-minute surgical delay.No patient injury was reported.Two screws were returned for evaluation; it is unknown which screw is associated with which fracture.This report is for lot cr46075c.
Additional Manufacturer Narrative
Investigation of the returned part is ongoing.Possible adverse events bending, disassembly, or fracture of implant and components.
Additional Manufacturer Narrative
The screw shanks and heads were returned and evaluated by product engineering.Visual inspection confirmed that they had fractured at the point where the screw head transitions into the shank.Internal testing has shown that screws inserted into pilot holes prepped via probes experienced greater maximum insertion torque than those inserted into pilot holes prepped via drill or drill and tap.An increased insertion torque can put more stress on the screw, potentially leading to fracture.Drill and tap instrumentation is included in the northstar system.Possible adverse events : bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's northstar posterior cervical fusion system.A polyaxial, favored angle screw broke just below the screw head during insertion into the left side of the t1 vertebrae.A second polyaxial, favored angle screw broke at the same point during insertion into the right side of the t1 vertebrae.Both screw shafts were removed from the patient.This resulted in a 20 to 30-minute surgical delay.A straight probe had been used to create both screw pilot holes.No patient injury was reported.Two screws were returned for evaluation; it is unknown which screw is associated with which fracture.This report is for lot cr46075c.

• Brand Name: NORTHSTAR POLYAXIAL SCREW, FAVORED ANGLE
• Common Device Name: 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19584604
• Report Number: 3012120772-2024-00037
• Device Sequence Number: 17020778
• Product Code: NKG
• UDI-Device Identifier: 10889981197308
• UDI-Public: 10889981197308
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K231654
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: PC1-105534
• Device Catalogue Number: PC1-105534
• Device Lot Number: CR46075C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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