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

Model Number	41-1010
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Revision surgery is pending; no date was provided to the manufacturer.The extent of the construct is not known at this time and no radiographs have been received.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
Event or Problem Description
Surgeon reported that a set screw backout occurred approximately 6 months post-operation.The report noted the loosening occurred at the bottom of the construct.While surgical revision is planned, there is no definitive date for the surgery between the date that the issue was reported and the time of this report.There were no products returned for evaluation at the time of this report.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SCREW SET
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12481904
• Report Number: 3012120772-2021-00073
• Device Sequence Number: 4345735
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/15/2021

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: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1