MAUDE Adverse Event Report: SEASPINE, INC MARINER; MARINER - 10889981155100

Model Number 41-1010

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

Patient underwent initial procedure on (b)(6) 2020.During follow-up ct scan, it was noticed by the surgeon, that the set screw no longer locked into the polyaxial head.The surgeon decided to reoperate on this patient, to remove the set screw and polyaxial head and replace with the new ones.The reason for the loosening is unknown.

• Brand Name: MARINER
• Type of Device: MARINER - 10889981155100
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: joseph bautista ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 12782870
• MDR Text Key: 284634510
• Report Number: 3012120772-2021-00081
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K212692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Device Lot Number: AW108543C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1