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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 Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Seaspine was made aware of this event on 30 mar 2021. At this time, no explants have been made available for analysis. No additional details have been communicated to seaspine regarding the patient's condition and treatment plan. Review of labeling: possible adverse events: -delayed union or nonunion (pseudarthrosis).
 
Event Description
The patient underwent l3-s1 spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system. In a twelve month postoperative follow up appointment, ct scan showed pseudarthrosis at l5-s1, air in the si joints, and failed fusion. The surgeon elected to administer a bilateral si joint injection and revise the construct to extend it to l1-pelvis.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceMARINER PEDICLE 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
macy nicol
5770 armada dr.
carlsbad, CA 92008
7602165137
MDR Report Key11742339
MDR Text Key250244596
Report Number3012120772-2021-00033
Device Sequence Number1
Product Code NKB
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 study,user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
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

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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