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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICLE SCREW SYSTEM; SCREW SET
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SEASPINE, INC MARINER PEDICLE SCREW SYSTEM; SCREW SET Back to Search Results
Model Number 41-1010
Medical Device Problem Code Separation Problem (4043)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
There were very minimal details provided when this complaint was reported.Attempts for follow up have netted no details regarding the 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.
 
Event or Problem Description
On (b)(6) 2021, it was reported that backed out screws were observed during a procedure.There were no responses from the reporter or the facility to follow up attempts requesting further information.
 
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Brand Name
MARINER PEDICLE SCREW SYSTEM
Common Device Name
SCREW SET
Manufacturer (Section D)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
MDR Report Key12380783
Report Number3012120772-2021-00072
Device Sequence Number11896238
Product Code NKB
UDI-Device Identifier10889981155100
UDI-Public10889981155100
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K173882
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number41-1010
Device Catalogue Number41-1010
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/29/2021
Initial Report FDA Received Date08/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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