MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER MIS POLYAXIAL HEAD; SCREW HEAD

Model Number	MM1-000020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the returned parts is ongoing.The following reports are also related: 3012120772-2024-00048, 3012120772-2024-00049, 3012120772-2024-00050, 3012120772-2024-00051, 3012120772-2024-00052, 3012120772-2024-00053, 3012120772-2024-00055, 3012120772-2024-00056, 3012120772-2024-00057, possible adverse events loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery consisting of seaspine's mariner mis posterior fixation system.On or around (b)(6) 2024, it was observed that "there was a tulip disengagement and set screw fall out post op." revision surgery occurred on (b)(6) 2024.No patient injury was reported.Multiple products were explanted and returned; it is unknown which units were associated with the failure.This report is for 4 of 7 units of lot te183452e.
Additional Manufacturer Narrative
The parts were returned and analyzed by product engineers.Visual inspection noted damage to the washer component of 1 unit of mm1-000020 mis polyaxial head, lot: te183452e (3012120772-2024-00051), and non-uniform wear to 1 unit of md1-100016 pointlock set screw, lot: aw167907b (3012120772-2024-00028) and 1 unit of md1-100016 pointlock set screw, lot: aw167910b (3012120772-2024-00047).See related reports for evaluation results.No damage was observed on this unit; it is believed to not have contributed to the reported failures.The following reports are also related: 3012120772-2024-00048, 3012120772-2024-00049, 3012120772-2024-00050, 3012120772-2024-00051, 3012120772-2024-00052, 3012120772-2024-00053, 3012120772-2024-00055, 3012120772-2024-00056, 3012120772-2024-00057.Possible adverse events: loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery consisting of seaspine's mariner mis posterior fixation system.On or around (b)(6) 2024, it was observed that "there was a tulip disengagement and set screw fall out post op." revision surgery occurred on (b)(6) 2024.No patient injury was reported.10 md1-100016 pointlock set screws and 10 mm1-000020 mis polyaxial heads were returned; at the time of the initial report it was unknown which units were associated with the failure.This report is for 4 of 7 units of lot te183452e.

• Brand Name: MARINER MIS POLYAXIAL HEAD
• Common Device Name: SCREW HEAD
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19590076
• Report Number: 3012120772-2024-00054
• Device Sequence Number: 16982707
• Product Code: NKB
• UDI-Device Identifier: 10889981177805
• UDI-Public: 10889981177805
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K232566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: MM1-000020
• Device Catalogue Number: MM1-000020
• Device Lot Number: TE183452E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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
• Patient Sex: Unknown