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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 41-1010
Device Problem Premature Separation (4045)
Patient Problem Failure of Implant (1924)
Event Date 04/11/2022
Event Type  malfunction  
Manufacturer Narrative
Review of provided x-ray confirms several set screws have loosened. No surgical intervention is planned at this time. 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 utilizing seaspine's mariner pedicle screw system on (b)(6) 2021. Seaspine was made aware on (b)(6) 2022 that set screws had loosened from the construct in the postoperative period.
 
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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
amanda fonseca
5770 armada dr.
carlsbad, CA 92008
MDR Report Key14342789
MDR Text Key291383715
Report Number3012120772-2022-00019
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981155100
UDI-Public10889981155100
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212692
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 05/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number41-1010
Device Catalogue Number41-1010
Was Device Available for Evaluation? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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