MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER POINTLOCK SET SCREW

Model Number	MD1-100016
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: 3012120772-2024-00049, 3012120772-2024-00050, 3012120772-2024-00051, 3012120772-2024-00052, 3012120772-2024-00053, 3012120772-2024-00054, 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 1 of 4 units of lot aw167907b.
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).The set screw wear is indictive of being locked down on the rod's inserter engagement feature, resulting in insufficient overhand at the end of the construct.Alternately, this could be the result of undersized rod selection, or excessive intra-operative compression or distraction.It is suspected that this would lead to the failure of the head's washer component.The set screw wear could also result from being locked down on a rod that is not fully normalized to the head.The following reports are also related: 3012120772-2024-00049, 3012120772-2024-00050, 3012120772-2024-00051, 3012120772-2024-00052,3012120772-2024-00053, 3012120772-2024-00054, 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 1 of 4 units of lot aw167907b.

• Brand Name: MARINER POINTLOCK SET SCREW
• Common Device Name: SCREW
• 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: 19584952
• Report Number: 3012120772-2024-00028
• Device Sequence Number: 7279398
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• 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: MD1-100016
• Device Catalogue Number: MD1-100016
• Device Lot Number: AW167907B
• 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: 09/19/2023
• 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