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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 Date 10/28/2020
Event Type  Injury  
Event Description
A patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system and seaspine's regatta and reef to intervertebral fusion devices on (b)(6) 2020. On (b)(6) 2022, it was reported that a revision surgery occurred on (b)(6) 2020 to replace three mariner set screws that loosened in the postoperative period. Two of the three set screws reportedly loosened a second time, prompting a second revision surgery, which occurred on (b)(6) 2022, prompting report 3012120772-2022-00001.
 
Manufacturer Narrative
Review of the x-rays provided confirmed that the set screws in the iliac had separated from the construct. A revision surgery occurred on (b)(6) 2020 to reinstrument the failed hardware. Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components 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 Key13444909
MDR Text Key287279335
Report Number3012120772-2022-00002
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 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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? No
Date Manufacturer Received01/04/2022
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: 02/03/2022 Patient Sequence Number: 1
Treatment
SEASPINE'S REEF TO INTERBODY; SEASPINE'S REGATTA LATERAL INTERBODY
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