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	Insufficient Information (4580)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Seaspine was made aware of a post-op loosening event on (b)(6) 2022 at occurred 5 months ((b)(6) 2022) prior to the event date ((b)(6) 2022).The case was for fracture at l4 on a 46 year old male.It was completed in a percutaneous fashion using the largest screws the pedicle would hold as well as a 6.0cocr rod.A 105 in/lb torque was used on regular set caps to final lock everything.This report is for 2 of 2 lot numbers provided.This report was "originally" filed under 3012120772-2022-00031 but reported two lot numbers.This report separates out lot aw135871d.Lot aw135865d was reported on 3012120772-2023-00024.
Additional Manufacturer Narrative
This report was originally filed under 3012120772-2022-00031 but reported two lot numbers.This report separates out lot aw135871d.Lot aw135865d was reported on 3012120772-2023-00024.Review of provided x-ray confirms at least one set screw has loosened.No surgical intervention is planned at this time.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
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 17599098
• Report Number: 3012120772-2023-00018
• Device Sequence Number: 7420450
• 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: 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): 08/22/2023

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
• Device Lot Number: AW135871D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: 105 IN/LB TORQUE DRIVER; 6.0 COCR ROD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male