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

Model Number 41-1010

Device Problem Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The patient is currently asymptomatic and no medical treatment or intervention is planned or required at this time.Based on the information available and recent similar investigations, the failure mode is loss of grip strength between the set screw, connector, screw head assy, and rod.The issue may manifest as separation of components, rod slippage via radiography, or reported as popping/clicking/squeaking/scraping sounds which may emanate during movement.Grip strength is dependent on complete fitment/alignment of the mating components (i.E., complete reduction).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 Description

A (b)(6) patient was diagnosed with scoliosis, lumbar flatback, severe stenosis, neurogenic claudication, and bilateral lower extremity radiculopathy.The patient underwent a thoracolumbar fusion surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system from t10-s2.Seaspine was made aware that several set screws loosened in the postoperative period requiring revision surgery (reference previous submission: 3012120772-2020-00080 (seaspine complaint #(b)(4)).The revision surgery occurred on (b)(6) 2020 to replace a disarticulated screw at the s2ai level with a competitor's screw in addition to the five loosened seaspine mariner set screws.The distributor confirmed all set screws were re-tightened and torqued to seaspine specifications.It was also reported that the patient returned for a follow up visit post-revision surgery and the five previously revised mariner set screws had loosened.The patient is currently asymptomatic and no intervention is planned at this time.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: 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 ; 6122753395
• MDR Report Key: 11611282
• MDR Text Key: 250247179
• Report Number: 3012120772-2021-00027
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR