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

Model Number	MD1-100016
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012120772-2022-00018
• Device Sequence Number: 4661360
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown