MAUDE Adverse Event Report: SEASPINE, INC MARINER OUTRIGGER; MARINER OUTRIGGER REVISION SYSTEM

Model Number 99-1023-12

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Inspection upon receiving at the manufacturer observed gouges consistent with the devices being used.Follow up with the customer representative describes the allegation of metallosis may have been an inaccurate description of what was observed, as the surgeon may have been referring to the presence of gouges (origin unconfirmed) on the connectors.There has, additionally, been no evidence to support the report of metallosis (physiologic response to implant secondary to wear debris or measured serum metal ion levels).There were no films provided to show the connectors in situ.Evaluation of the devices is ongoing.

Event Description

On (b)(6) 2021, a procedure was performed, at which time the referenced products were implanted for spinal deformity from t10 to the iliac spine level.During a revision surgery on (b)(6) 2021, the surgeon observed a proximal fracture above t10, so the surgeon extended the surgery to t3 using the connectors between the previous surgery and the new surgery.Also observed at the time was what the surgeon referred to as "abundant metallosis".There has been no supporting evidence provided for the finding of metallosis (physiologic response to implant secondary to wear debris or measured serum metal ion levels).Follow-up with the customer representative describes the allegation of metallosis may have been an inaccurate description of what was observed, and the surgeon may have been referring to the presence of witness marks (origin unconfirmed) on the connectors.Additionally, the side connector on one side was found 'out' and the connector on the contralateral side was observed to be loose.The spine levels covered were t10-t3, and the spine levels affected were t10 and above.

• Brand Name: MARINER OUTRIGGER
• Type of Device: MARINER OUTRIGGER REVISION SYSTEM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12426102
• MDR Text Key: 280590887
• Report Number: 3012120772-2021-00070
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981184940
• UDI-Public: 10889981184940
• Combination Product (y/n): N
• PMA/PMN Number: K183639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-1023-12
• Device Catalogue Number: 99-1023-12
• Device Lot Number: TE129574F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 99-1016-12 PARALLEL, CLOSED/SIDE-LOADING, 8MM
• Patient Outcome(s): Other
• Patient Age: 83 YR