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U.S. Department of Health and Human Services

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

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SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM SET SCREW Back to Search Results
Model Number 411000
Device Problems Separation Failure (2547); Premature Separation (4045)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Based on visual inspection and analysis of the returned components, it was determined that the explants are from different generations of the mariner pedicle screw system. The screw tulips returned are mariner gen 2 with the rhomboid thread, and the set screws are mariner gen 1 with the square thread. These implants are not intended to be paired together and likely contributed to the failure reported. There was no significant damage or issues noted while inspecting the returned components other than the mismatched generations. 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 patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system on (b)(6) 2021. It was reported that the patient heard pops and felt pain postoperatively. During a 4-week follow up appointment, it was discovered that 2 set screws separated from the construct. The surgeon and patient elected to proceed with a revision surgery, which took place on (b)(6) 2021 and consisted of explanting the seaspine hardware and replacing with another manufacturer's. The seaspine explants were returned to seaspine for analysis on (b)(6) 2021.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceSET 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
7602165137
MDR Report Key11780920
MDR Text Key249242774
Report Number3012120772-2021-00038
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981065065
UDI-Public10889981065065
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 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number411000
Device Catalogue Number411000
Device Lot NumberAW78876B/AW85285B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2021 Patient Sequence Number: 1
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