MAUDE Adverse Event Report: SEASPINE, INC. MARINER SET SCREW

Model Number	41-4010
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient underwent revision surgery on (b)(6) 2021, for unspecified reasons at which time it was noted that 1 of 6 lock screws had backed out.The root cause of this event cannot be determined at this time as no implants or x-rays were made available for analysis.The reason for the revision surgery is unknown at this time, and no additional information was provided.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
Patient underwent revision surgery on (b)(6) 2021, for unspecified reasons at which time it was noted that 1 out of 6 lock screws had backed out.The product is not available for return.The reason for the revision surgery is unknown and no additional information was provided.

• Brand Name: MARINER SET SCREW
• Common Device Name: SET SCREW
• Manufacturer (Section D): SEASPINE, INC.; 5770 armada drive; carlsbad CA 92069
• MDR Report Key: 12124751
• Report Number: 3012120772-2021-00063
• Device Sequence Number: 4987706
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 41-4010
• Device Catalogue Number: 41-4010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/06/2021
• 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