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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE, INC. MARINER SET SCREW

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SEASPINE, INC. MARINER SET SCREW Back to Search Results
Model Number 41-4010
Device Problems Loose or Intermittent Connection (1371); Separation Problem (4043)
Patient Problem Failure of Implant (1924)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Patient underwent revision surgery on (b)(6) 2021, for unspecified reasons at which time it was noted that 1 of 6 lock screws had backed out.The root cause of this event cannot be determined at this time as no implants or x-rays were made available for analysis.The reason for the revision surgery is unknown at this time, and no additional information was provided.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
Patient underwent revision surgery on (b)(6) 2021, for unspecified reasons at which time it was noted that 1 out of 6 lock screws had backed out.The product is not available for return.The reason for the revision surgery is unknown and no additional information was provided.
 
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Brand Name
MARINER SET SCREW
Type of Device
SET SCREW
Manufacturer (Section D)
SEASPINE, INC.
5770 armada drive
carlsbad CA 92069
Manufacturer (Section G)
SEASPINE, INC
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
taara maharaj
5770 armada drive
carlsbad, CA 92008
9517042800
MDR Report Key12124751
MDR Text Key265008312
Report Number3012120772-2021-00063
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,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 07/06/2021
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
Device Operator Health Professional
Device Model Number41-4010
Device Catalogue Number41-4010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/08/2021
Initial Date FDA Received07/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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