• 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. MARINER MIS 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. MARINER MIS PEDICLE SCREW SYSTEM SET SCREW Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Based on a review of the postoperative images received, both set screws implanted at s1 separated from the construct. Multiple attempts were made to gather additional information; however, the index surgery information was not provided. Additionally, seaspine is not aware of any surgical intervention that occurred as a result of the reported malfunctions. A review of labeling notes: possible adverse events like other spinal system implants, the following adverse events are possible. This list is not exhaustive: delayed union or nonunion (pseudarthrosis) 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 pain, discomfort, or abnormal sensations due to the presence of the device increased biomechanical stress on adjacent levels. Improper surgical placement of the implant causing stress shielding of the graft or fusion mass. Intraoperative fracture, or perforation of the spine. Postoperative fracture due to trauma, defects, or poor bone stock. Postoperative warnings surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance. The patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised that implants may bend, break or loosen despite restriction in activity. The patient should be advised to avoid mechanical vibrations that may loosen the device. The patient should be advised not to smoke or consume alcohol during recovery.

 
Event Description

On 10 jun 2020, seaspine was made aware of two set screws that disassociated from the mariner mis pedicle screw construct during the postoperative period. Multiple attempts were made to gather additional information; however, the index surgery information was not provided. Additionally, seaspine is not aware of any surgical intervention that occurred as a result of the reported malfunctions.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMARINER MIS PEDICLE SCREW SYSTEM
Type of DeviceSET SCREW
Manufacturer (Section D)
SEASPINE INC.
5770 armada drive
carlsbad, ca
Manufacturer (Section G)
SEASPINE INC.
5770 armada drive
carlsbad, ca
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, ca 
2165137
MDR Report Key10252510
MDR Text Key227322736
Report Number3012120772-2020-00051
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK191648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 07/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
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

-
-