MAUDE Adverse Event Report: SEASPINE, INC MARINER MIS CANNULATED SCREW

Model Number 41-6545-2

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation as the screw remains implanted.The customer reported that the patient was asymptomatic.No revision surgery is planned.Possible adverse events: bending, disassembly, or fracture of implant and components.

Event Description

On (b)(6) 2023, a patient underwent spinal surgery consisting of the mariner mis posterior fixation system.Seaspine was made aware on 9 feb 2024 that a 41-6545-2 cannulated screw 6.50 x 45mm had fractured at the neck at s1.The patient is asymptomatic, and no revision surgery is planned.

• Brand Name: MARINER MIS CANNULATED SCREW
• Type of Device: SCREW
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 18839051
• MDR Text Key: 337020347
• Report Number: 3012120772-2024-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981068240
• UDI-Public: 10889981068240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41-6545-2
• Device Catalogue Number: 41-6545-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female