MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICLE SCREW SYSTEM

Model Number	41-7545-1
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clinical circumstances did not warrant removal; dr.Miller states they have no intent to removed the screw at this time.There were no pictures or radiographs provided to confirm the report of a broken screw.The surgeon will continue to monitor the patient for any indication prompting additional treatment.Possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: bending, disassembly or fracture of implant and components.
Event or Problem Description
Approximately 6 months post-op, a screw fractured at the neck of the screw shank where the tulip meets the screw shank.The side of the patient is not discernible on xray.Dr.(b)(6) no intentions of taking the patient back to surgery and removing it.He will just follow the patient for the time being because it is not symptomatic.Surgeon: dr.(b)(6).Hospital: (b)(6).Levels: l3-s1 screws.Issue: screw fracture at s1, screw size: 7.5x45.Original date of surgery: (b)(6) 2020.Discovery date: (b)(6) 2021.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12186095
• Report Number: 3013130772-2021-00065
• Device Sequence Number: 4712888
• Product Code: NKB
• UDI-Device Identifier: 10889981068974
• UDI-Public: 10889981068974
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 41-7545-1
• Device Catalogue Number: 41-7545-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other