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U.S. Department of Health and Human Services

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

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SEASPINE, INC MARINER PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Osseointegration Problem (3003)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
Patient in for follow-up visit and radiographs demonstrated good fixation except for the t10 junction -mild amount of pulling and haloing. The patient will be evaluated in 12 months for proximal junction failure. Possible adverse events like other spinal system implants, the following adverse events are possible. This list is not exhaustive: bending, disassembly or fracture of implant and components.
 
Event Description
Patient in for follow-up visit and radiographs demonstrated good fixation except for the t10 junction -mild amount of pulling and haloing. The patient will be evaluated in 12 months for proximal junction failure.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceSCREW
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 Key14119065
MDR Text Key298798445
Report Number3013130772-2022-00016
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/15/2022 Patient Sequence Number: 1
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