• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. SEASPINE MARINER PEDICLE SCREW SYSTEM SET SCREW

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SEASPINE INC. SEASPINE MARINER PEDICLE SCREW SYSTEM SET SCREW Back to Search Results
Model Number 41-1010
Device Problems Detachment of Device or Device Component (2907); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
The implant was not made available for review as it remains in-site; however review of the x-ray provided confirms the s1 set screw disassociated from the construct. The patient is asymptomatic and the surgeon will continue to monitor for any indication prompting surgical intervention. 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.
 
Event Description
A patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system from l5-s1. Seaspine was made aware on (b)(6) 2020 of a postoperative set screw disassociation at the s1 level.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSEASPINE MARINER PEDICLE SCREW SYSTEM
Type of DeviceSET SCREW
Manufacturer (Section D)
SEASPINE INC.
5770 armada drive
carlsbad CA 92008
Manufacturer (Section G)
SEASPINE INC.
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, CA 92008
7602165137
MDR Report Key10909102
MDR Text Key241813656
Report Number3012120772-2020-00091
Device Sequence Number1
Product Code NKB
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
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number41-1010
Device Catalogue Number41-1010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
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

-
-