MAUDE Adverse Event Report: SEASPINE, INC MARINER; SET SCREW

Model Number	41-1010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intra-op image shows the rod is engaged with both superior and inferior screws.The post-operative image confirms that the rod has translated inferiorly and is completely disengaged from the superior screw.A revision surgery occurred on (b)(6) 2022.Explants were returned for evaluation, but no failures were observed.The amount of translation in combination with the appearance of the implants indicates that the user likely failed to final tighten this side of the construct, allowing the rod to translate postoperatively.
Event or Problem Description
Patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system on (b)(6) 2022.On (b)(6) 2022 it was identified that the s1 set screw loosened, causing the rod to disengage from the superior tulip head and slid inferiorly.Removal and re-instrumentation of the fixation occurred on (b)(6) 2022.Seaspine was made aware of this event on (b)(6) 2022.There were 2 screws and 1 rod p/n mm1-155040) involved in this single event.Lot numbers aw154138d/aw127247d.

• Brand Name: MARINER
• Common Device Name: SET SCREW
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 16039948
• Report Number: 3012120772-2022-00056
• Device Sequence Number: 20388213
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Device Lot Number: AW154138D/AW127247D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown