MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER; MARINER PEDICLE SCREW SYSTEM

Model Number	MD1-100016
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Seaspine was made aware on (b)(6) 2023 that an md1-100016 pointlock set screw disengaged post-operatively from s1 and the rod is no longer attached.The index surgery was performed on (b)(6) 2023.The locking cap on s1 from had disengaged and the rod was no longer attached.While the case sheet provided indicates another screw, additional information provided states that the screw that disengaged is a md1-100016 pointlock set screw.The device was not removed, and the case is not being revised at this time, as the patient is asymptomatic.It is possible that the patient can form a solid fusion from the interbody and biologics used and contralateral hardware compression without the need of enduring another procedure.
Event or Problem Description
Seaspine was made aware on (b)(6) 2023 that an md1-100016 pointlock set screw disengaged post-operatively from s1 and the rod is no longer attached.The index surgery was performed on (b)(6) 2023.The locking cap on s1 from had disengaged and the rod was no longer attached.While the case sheet provided indicates another screw, additional information provided states that the screw that disengaged is a md1-100016 pointlock set screw.

• Brand Name: MARINER
• Common Device Name: MARINER PEDICLE SCREW SYSTEM
• 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: taara maharaj ; 5770 armada dr.; carlsbad ; 7602165150
• MDR Report Key: 18145138
• Report Number: 3012120772-2023-00030
• Device Sequence Number: 7512518
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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: MD1-100016
• Device Catalogue Number: MD1-100016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MD1-100016 POINTLOCK SET SCREW.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male