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)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report of screws loosening was reported on (b)(6) 2021.There was no information on whether this was a revision or a review surgery.The reporter indicated that 2 set screws were loose.Subsequent follow up was not able to obtain additional information.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
Doctor conducted a removal of implants on a patient that had an l3-s1 alif + post screw fixation with mis mariner on (b)(6) 2021.Upon removing the s1 and l5 screws, he noticed that the set screws had loosened significantly.Although the set screws did not fully remove, the there was no torque retained on the implants.Of note, the index surgery was performed with 85lb torque limiters on (b)(6) 2020.Images were provided that show the bottoms of the set screws that were loose.

• 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: 12677646
• Report Number: 3012120772-2021-00078
• Device Sequence Number: 14506243
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 09/21/2021
• Initial Report FDA Received Date: 10/21/2021
• 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