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U.S. Department of Health and Human Services

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

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SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM POINTLOCK SET SCREW Back to Search Results
Model Number MD1-100016
Device Problem Premature Separation (4045)
Patient Problem Failure of Implant (1924)
Event Date 03/17/2022
Event Type  malfunction  
Manufacturer Narrative
Review of the x-ray provided confirms one pointlock set screw loosened in the postoperative period. Additional units of separation are unable to be confirmed via x-ray. A singular cause in these cases is not evident. Identified associations with loss of construct rigidity include long constructs (including the s2ai spine segment), heavy intra-operative clinical manipulation (e. G. , spinal derotation), and method/order of construct tightening. Failure modes are dependent on numerous factors, including, but not limited to, patient selection, pathology, surgical plan, technique, and implant/instrument design. Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
 
Event Description
A patient underwent a 1 level spinal surgery from level l4-l5 on (b)(6) 2021 consisting of seaspine's mariner pedicle screw system. Seaspine was made aware that multiple set screws loosened 2 months postoperatively.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DevicePOINTLOCK SET 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
audrey mudderman
5770 armada dr.
carlsbad, CA 92008
7602165137
MDR Report Key14115647
MDR Text Key298776601
Report Number3012120772-2022-00015
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981283803
UDI-Public10889981283803
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 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 Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMD1-100016
Device Catalogue NumberMD1-100016
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2022
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: 04/14/2022 Patient Sequence Number: 1
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