MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER; FIXED SCREW

Device Problems Loss of or Failure to Bond (1068); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Revision surgery performed on (b)(6) 2021.Left side screws appeared tight per surgeon.Right side screws: t10 off (visible on pre-op xray), t11 loose/off, t12 off, l1 loose.New set screws were placed (right side t10-l1), counter torque and final tightening was completed.New set screws (md1-100016, point loading set screw.Torqued to 110 inlb.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

During case performed on (b)(6) 2021, surgeon torqued and then broke off tabs on left side of hardware.This was a deviation from what he has been doing and also from was done on right side of patient.

• Brand Name: MARINER
• Type of Device: FIXED 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: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13239563
• MDR Text Key: 286146170
• Report Number: 3012120772-2021-00099
• Device Sequence Number: 1
• Product Code: MNI
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female