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

Model Number	41-1010
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of provided x-ray confirms screw loosening and observes a fractured rod.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
Seaspine was notified on (b)(6) 2022 of a screw back out event.On the films provided, there was also a rod fracture observed.
Additional Manufacturer Narrative
Review of the x-ray provided confirmed the allegation of postoperative set screw loosening.The initial report submitted associated with this failure suggested a rod fractured in addition to the set screw loosening; however, further review of the information and x-ray provided confirmed the rod is fully in tact, prompting this follow up report.Furthermore, the operating surgeon also confirmed the rod did not fracture.The root cause of the set screw loosening cannot be determined at this time as no implants were made available for analysis and no additional information surrounding the surgical technique and/or events leading up to the failure were provided.Failure modes are dependent on numerous factors, including, but not limited to, patient selection, pathology, surgical plan, technique, and implant/instrument design.Possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.
Event or Problem Description
A patient underwent spinal surgery consisting of seaspine's mariner mis pedicle screw system from levels l4-s1.Seaspine was made aware on 16 aug 2022 that a set screw loosened from the construct in the postoperative period.A rod fracture was also initially observed by seaspine product management via the x-rays provided.

• 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 ; 7607278399
• MDR Report Key: 15415031
• Report Number: 3012120772-2022-00034
• Device Sequence Number: 20459747
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 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: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 06/21/2023
• 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: MM1-15YXXX MIS PRECONTOURED ROD.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown