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U.S. Department of Health and Human Services

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

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SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Stenosis (2263); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
The root cause was not determined. Adjacent segment degeneration is a condition that sometimes occurs after spinal fusion surgery. Whether the degeneration is a result of a previous fusion attempt or the patient's predisposition to continued degeneration is unknown.
 
Event Description
The patient reported she had recently had 2 heart stents placed in (b)(6) of 2021 and now has an onset of right-sided thoracic and rib pain right at the top of her incision that radiates around towards the right lateral ribcagre area. Possible arthrosis at the level above the fusion contributing to foraminla stenosis likely causing thoracic radiculopathy.
 
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Brand NameMARINER
Type of DevicePEDICLE SCREW SYSTEM
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
joseph bautista
5770 armada dr.
carlsbad, CA 92008
7602165137
MDR Report Key13944011
MDR Text Key293538204
Report Number3012120772-2022-00012
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2022
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: 03/29/2022 Patient Sequence Number: 1
Treatment
125 CC COURSE ALLOGRAFT CHIPS; AUTOGRAFT; DBM TYPE - 15.4CC MAGNIFUSE, 10CC LARGE STRAND
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