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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICLE SCREW SYSTEM SCREW SET

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SEASPINE, INC MARINER PEDICLE SCREW SYSTEM SCREW SET Back to Search Results
Model Number 41-1010
Device Problems Loose or Intermittent Connection (1371); Separation Failure (2547)
Patient Problem Failure of Implant (1924)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
Patient underwent revision surgery on (b)(6) 2021 for unspecified reasons at which time it was observed that the posterior fixation construct was loosening in 3-level construct from l4-s1, on both sides. The root cause of this event cannot be determined at this time as no implants were made available for analysis. The reason for the revision surgery is unknown currently. It was noted that dr. (b)(6) replaced all previous hardware and fused up to l3 using the mariner system. 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 a revision surgery, dr. (b)(6) observed that the posterior fixation construct was loosening in 3-level construct from l4-s1, on both sides. This occurred 6 months post-operatively. Loosening appears to be at the s1 spine level bilaterally based on ct imaging. The index surgery was performed in (b)(6) of 2020. The case was a previous fusion at l5-s1. Dr. (b)(6) replaced all previous hardware and fused up to l3 using the mariner system.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceSCREW SET
Manufacturer (Section D)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
Manufacturer (Section G)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
taara maharaj
5770 armada drive
carlsbad, CA 92008
9517042800
MDR Report Key12146954
MDR Text Key261055737
Report Number3012120772-2021-00064
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number41-1010
Device Catalogue Number41-1010
Device Lot Number10889981155100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/09/2021 Patient Sequence Number: 1
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