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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explanation for h3: device is currently being evaluated, however, findings are not yet available, results pending outcome of investigation.Review of labeling: 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, it was observed via x-ray that there was a potential loosening/migration of a mariner mis rod in a patient.The surgeon scheduled a revision surgery on (b)(6) 2024.Customer reports patient is asymptomatic and there was no alleged patient injury.Although requested, no further information was provided.See mdr 3012120772-2024-0068 for pn mm1-155035, 3012120772-2024-00085 for one of the returned pn md1-100016, 3012120772-2024-00086 for pn mm1-000020 and 3012120772-2024-00087 for pn 41-7555-2.
Additional Manufacturer Narrative
Update to h3: device evaluated by manufacturer changed to "yes".The screws and rod were returned and evaluated by product engineering.Visual inspection determined there were markings on the rod and set screw and it appears the rod was pulled from the tulip, such that the dimple "fell off" the end of the rod and into the rod inserter feature.One of the set screws presented with excessive or unusual marring around the top chamfer of the hexalobe.This may be an indication that the final driver was not fully engaged and therefore, the full locking torque wasn't delivered.Product engineering identified the set screw was at least provisionally locked, but the marring and the sliding both indicate that it was not final locked.Review of labeling: 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, it was observed via x-ray that there was a potential loosening/migration of a mariner mis rod in a patient.The surgeon scheduled a revision surgery on (b)(6) 2024.Customer reports patient is asymptomatic and there was no alleged patient injury.Although requested, no further information was provided.See mdr 3012120772-2024-0068 for pn mm1-155035, 3012120772-2024-00085 for one of the returned pn md1-100016, 3012120772-2024-00086 for pn mm1-000020 and 3012120772-2024-00087 for pn 41-7555-2.

• 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 20258443
• Report Number: 3012120772-2024-00088
• Device Sequence Number: 12653356
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K232566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MD1-100016
• Device Catalogue Number: MD1-100016
• Device Lot Number: AW159785B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: Other
• Patient Sex: Unknown