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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 Type  Injury  
Manufacturer Narrative
A second revision surgery was performed to reinstrument the construct. The suspect/explanted device has not been returned to seaspine for analysis. Review of the x-ray provided confirms the s1 set screw loosened from the construct in the postoperative period. It is unknown if the x-rays provided were post-index surgery or post-revision surgery. All surgery dates and details are unknown. The cause of this event cannot be determined at this time as no additional information surrounding the surgical technique and/or events leading up to the failure were provided. Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components.
 
Event Description
A patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system from levels l4-s1; index surgery date unknown. It was reported that a set screw loosened from the construct 3 weeks post-operation. A revision surgery was performed to reinstrument the construct (ref: 3012120772-2021-00052) and while no explants were made available for analysis, review of the x-ray provided confirmed a set screw loosened from the s1 level in the postoperative period. It was also reported that 2 weeks post-revision surgery, the set screw at the s1 level that had been revised also became loose.
 
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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
taara maharaj
5770 armada drive
carlsbad, CA 92008
9517042800
MDR Report Key11943790
MDR Text Key254595756
Report Number3012120772-2021-00053
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981155100
UDI-Public10889981155100
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number41-1010
Device Catalogue Number41-1010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
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: 06/05/2021 Patient Sequence Number: 1
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