MAUDE Adverse Event Report: SEASPINE, INC NORTHSTAR; POLY. SCREW, 3.5MM X 24MM

Model Number	PC1-003524
Medical Device Problem Codes	Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conversations with the distributor revealed that the patient's bone was extremely sclerotic, specifically on the patient's right hand side.Additionally, it was discovered proper surgical technique was not followed.The screw tapping/preparation was completed with incorrect instrumentation.As a result of the incorrect instrumentation used, additional insertion torque was required, resulting in excessive load placed on the implant, thus leading to the fracture reported.
Event or Problem Description
A patient underwent c4-t1 spinal surgery (b)(6) 2021 as the result of a motor vehicle accident.The patient reportedly had an unstable cervical spine with neurologic deficit.Upon insertion of the final screw (right c4), the screw fractured.The surgeon attempted to remove the screw with a screw extractor; however, the screw fractured again and was left inside the lateral mass.

• Brand Name: NORTHSTAR
• Common Device Name: POLY. SCREW, 3.5MM X 24MM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: joseph bautista ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 13047884
• Report Number: 3012120772-2021-00090
• Device Sequence Number: 1609445
• Product Code: NKG
• UDI-Device Identifier: 10889981196004
• UDI-Public: 10889981196004
• 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): 12/20/2021

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: PC1-003524
• Device Catalogue Number: PC1-003524
• Device Lot Number: CR44737B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (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