MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER; MARINER - 10889981283803

Model Number MD1-100016

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2021

Event Type  Injury  

Event Description

On (b)(6) 2022, seaspine was made aware that a surgeon reported likely set screw loosening post-op.X-rays taken approximately 3 months after the revision surgery shows what appears to be 3 loose set screws.The customer noted that as of 07 april 2022, there is no revision surgery scheduled for this patient.No implants were made available for analysis as no revisions have occurred.Thus, no failure analysis has been performed for this complaint.

Manufacturer Narrative

The root cause of these events cannot be determined at this time as no implants were made available for analysis and no additional information surrounding the surgical technique and/or events leading up to the failures were provided.A singular cause in cases involving the md1-100016 point lock set screw loosening post-op is not evident.Identified associations with loss of construct rigidity include long constructs (including the s2ai spine segment), heavy intra operative clinical manipulation (e.G., spinal derotation), and method/order of construct tightening.

• Brand Name: MARINER
• Type of Device: MARINER - 10889981283803
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 14324171
• MDR Text Key: 293153737
• Report Number: 3012120772-2022-00018
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MD1-100016
• Device Catalogue Number: MD1-100016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• 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
• Patient Sequence Number: 1