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

Model Number	MD1-100016
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the x-ray provided confirms one pointlock set screw loosened in the postoperative period.Additional units of separation are unable to be confirmed via x-ray.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.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
A patient underwent a 1 level spinal surgery from level l4-l5 on (b)(6) 2021 consisting of seaspine's mariner pedicle screw system.Seaspine was made aware that multiple set screws loosened 2 months postoperatively.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: POINTLOCK 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: 14115647
• Report Number: 3012120772-2022-00015
• Device Sequence Number: 5755326
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• 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
• 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): 04/14/2022

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: MD1-100016
• Device Catalogue Number: MD1-100016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/14/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown