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

Model Number	41-1010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a 5 level spinal surgery from level l1-s1 on (b)(6) 2021 consisting of seaspine's mariner pedicle screw system.Seaspine was made aware of a revision surgery that took place on (b)(6) 2022 due to implants loosening from the construct in the postoperative period.
Additional Manufacturer Narrative
Review of the x-ray provided confirms six set screws loosened in the postoperative period.A singular cause in these cases is not evident.Identified associations with loss of construct rigidity include long constructs (including the s2ai spine segment), heavy intra-operative clinical manipulation (e.G., spinal derotation), and method/order of construct tightening.Failure modes are dependent on numerous factors, including, but not limited to, patient selection, pathology, surgical plan, technique, and implant/instrument design.Surgical instrumentation has not been associated with malfunctions related to the reported event.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.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SET SCREW
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 14043451
• Report Number: 3012120772-2022-00014
• Device Sequence Number: 14691748
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male