MAUDE Adverse Event Report: SEASPINE, INC MARINER MIS; MIS STRAIGHT ROD, 5.5 X 250MM

Model Number MM1-165250

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Set screws loosened and the rod became dislodged.Original date of surgery - (b)(6) 2021.Date of revision - (b)(6) 2021.Surgeon - scripps green procedure - llif + post screws l1-s1.Occurrence - within 1 month of the procedure it was discovered that the lower part of her construct had become dislodged.Patient was brought back for a revision surgery and it was discovered that s1 and l5 set screws had loosened.Thus, the rods "slid" out from under the set screws.We replaced the set screws and final tightened with the 105lb torque limiters.

Manufacturer Narrative

The report of the rod backing out was confirmed based on films provided to seaspine.The root cause has not been determined as there have been no devices or instruments returned for evaluation.The revision surgery occurred, and there has been no feedback or further information provided.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

• Brand Name: MARINER MIS
• Type of Device: MIS STRAIGHT ROD, 5.5 X 250MM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12724749
• MDR Text Key: 282111621
• Report Number: 3012120772-2021-00079
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K212692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MM1-165250
• Device Catalogue Number: MM1-165250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1