MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM; SET SCREW

Model Number	41-1010
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This event was originally reported on 3012120772-2022-00019.This report is for 3 of 5 lot numbers.A patient underwent spinal surgery utilizing seaspine's mariner pedicle screw system on (b)(6) 2021.Seaspine was made aware on 11 apr 2022 that set screws had loosened from the construct in the postoperative period.This was noted at the 6-month post-operative appointment.On 12 may 2022 seaspine was made aware that a revision surgery had occurred on (b)(6) 2022.Explants were returned on (b)(6) 2022.
Additional Manufacturer Narrative
This event was originally reported on 3012120772-2022-00019.Fifteen explanted set screws were returned for evaluation on 16 may 2022.Visual inspection noted that six of the set screws had striations across the bottom, indicative of them having come loose.Of these, four presented with unpolished surfaces in the middle of the set screw, indicating they were not completely normalized in the tulip.The remaining nine set screws all showed proper normalization, as evidenced by the polished interior.Additionally, the rods were returned and examined.A significant difference in rod curvature was observed.The root cause is likely related to the incomplete rod normalization on several of the set screws, potentially exacerbated from the inconsistent rod curvatures.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SET 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
• MDR Report Key: 17599745
• Report Number: 3012120772-2023-00021
• Device Sequence Number: 6535375
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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: 41-1010
• Device Catalogue Number: 41-1010
• Device Lot Number: AW127247D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 18-18-0600 COCR STR. ROD 5.5X600
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown