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

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

The mariner set screw was not returned for investigation.Additionally, no radiographs or lot information were provided for analysis.The study reports satisfactory patient results on three subsequent follow-up visits.Review of labeling: possible adverse events: 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 Description

Patient 141-014 underwent spinal surgery consisting of seaspine's mariner pedicle screw system on (b)(6) 2018.On (b)(6) 2018, it was identified that the right distal hardware at l3-l4 had become disarticulated from the set screw.Removal and re-instrumentation of the stated lumbar fixation occurred on (b)(6) 2018.Seaspine was made aware of this event on (b)(6) 2022 as part of clinical study documentation updates.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: MARINER SET SCREW
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15763557
• MDR Text Key: 303391429
• Report Number: 3012120772-2022-00050
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention