MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION NORTHSTAR; OCC SCREW, 4.0MM X 14

Model Number	PC1-714014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent spinal surgery consisting of seaspine's northstar system.Seaspine was made aware on (b)(6) 2023 that a pc1714014 occ screw, 4.0mm x 14 fractured in-situ.The fractured screw remained in the patient.The index surgery was on (b)(6) 2023.
Additional Manufacturer Narrative
The reported fracture was confirmed via photos provided by the customer however, the cause of the fracture was not identified.No other information regarding the reported event were provided by the customer other than the shank remained in the patient.There was no mention of any remedial actions or any adverse effects experienced by the patient, if any.Possible adverse events bending, disassembly or fracture of implant and components.
Event or Problem Description
A patient underwent spinal surgery consisting of seaspine's northstar system.Seaspine was made aware on (b)(6) 2023 that a (b)(4) occ screw, 4.0mm x 14 fractured in-situ.The fractured screw remained in the patient.The index surgery was on (b)(6) 2023.
Additional Manufacturer Narrative
Udi # was inadvertently omitted in the intial report.This supplemental provided the udi #.

• Brand Name: NORTHSTAR
• Common Device Name: OCC SCREW, 4.0MM X 14
• 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
• MDR Report Key: 16583547
• Report Number: 3012120772-2023-00004
• Device Sequence Number: 1635092
• Product Code: NKG
• UDI-Device Identifier: 10889981259648
• UDI-Public: 10889981259648
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: PC1-714014
• Device Catalogue Number: PC1-714014
• Device Lot Number: JB44171B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2022
• 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