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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 411010
Device Problems Separation Failure (2547); Premature Separation (4045)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
The surgeon and patient opted to perform a revision surgery on (b)(6) 2020.The distributor was unable to provide information surrounding the surgical technique, x-rays, or additional information surrounding the revision outcome and/or care plan.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 spinal surgery consisting of seaspine's mariner pedicle screw system on (b)(6) 2020.On (b)(6) 2020, it was reported that the right l4-l5 set screws separated from the tulip, the left l5 bone screw appeared loose, and the left l4 set screw separated from the construct in the postoperative period.
 
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Brand Name
MARINER PEDICLE SCREW SYSTEM
Type of Device
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 Key11754132
MDR Text Key250243804
Report Number3012120772-2021-00034
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number411010
Device Catalogue Number411010
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/01/2021
Initial Date FDA Received04/30/2021
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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