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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 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
Dr (b)(6) observed a loose set screw at s1. The issue was reported 28 jun 2021. There was no date provided for the event. The construct had been in place since (b)(6) 2021. There were no details provided regarding patient injury or a revision surgery at the time of this report. 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
On 28 jun 2021, it was reported that dr. (b)(6) observed a loose set screw at the s1 segment. The date of the event was not provided. The index surgery was performed (b)(6) 2021. There was no report of patient injury, or details regarding revision.
 
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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 Key12222206
MDR Text Key263435201
Report Number3012120772-2021-00067
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 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
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 Received06/29/2021
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: 07/23/2021 Patient Sequence Number: 1
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