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U.S. Department of Health and Human Services

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

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SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM SET SCREW Back to Search Results
Model Number 41-1010
Device Problem Premature Separation (4045)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
A patient underwent a 5 level spinal surgery from level l1-s1 on (b)(6) 2021 consisting of seaspine's mariner pedicle screw system. Seaspine was made aware of a revision surgery that took place on (b)(6) 2022 due to implants loosening from the construct in the postoperative period.
 
Manufacturer Narrative
Review of the x-ray provided confirms six set screws loosened in the postoperative period. 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. Surgical instrumentation has not been associated with malfunctions related to the reported event. 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.
 
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Brand NameMARINER PEDICLE SCREW SYSTEM
Type of DeviceSET 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 Key14043451
MDR Text Key288796228
Report Number3012120772-2022-00014
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981155100
UDI-Public10889981155100
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 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number41-1010
Device Catalogue Number41-1010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2022
Date Manufacturer Received03/14/2022
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: 04/07/2022 Patient Sequence Number: 1
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