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U.S. Department of Health and Human Services

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

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SEASPINE INC MARINER PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 41-1010
Device Problem Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 11/09/2018
Event Type  malfunction  
Manufacturer Narrative
Returned device was evaluated and found to meet specification. There is marring on the bottom of the lock screw confirming the device loosened while in use in-situ. No radiographs were provided. The degree of spinal instability is unknown. Dhr was reviewed and no nonconformances were found. It is unknown if the patient complied with post-op care instructions. There was no report that the patient sustained an impact/trauma of any sort. Review of labeling notes: possible adverse events bending, disassembly or fracture of implant and components. Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain. Postoperative fracture due to trauma, defects or poor bone stock. The root cause of this event cannot be determined. No conclusions can be drawn.
 
Event Description
On (b)(6) 2018 patient underwent posterior fixation surgery. Follow-up visit discovers a hematoma and set screw had disassociated from the screw tuplip. On (b)(6) 2018 revision surgery was performed to remove/replace l5 set screw and review construct. Surgeon felt the s1 screw was loose and removed/replaced it. No complications during revision. Surgeon will monitor patient progress.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
SEASPINE INC
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
aaron
5770 armada drive
carlsbad 92008
MDR Report Key8144648
MDR Text Key130623055
Report Number3012120772-2018-00030
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
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 NumberAW92797C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? Yes
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: 12/07/2018 Patient Sequence Number: 1
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