MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM; SOLID SCREW 6.50 X 50MM

Model Number	41-6550-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mariner solid screws were not returned for evaluation; however, photos of the two explanted fractured screws were provided.Both of the screws fractured at the neck of the screw.While a thorough analysis could not be performed since the product was not returned, pseudarthrosis/non-union is a potential contributing factor.If the patient's anatomy does not allow proper fusion, substantial loads will be placed on the implanted hardware, which may result in the fractures observed.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components.
Event or Problem Description
A patient underwent a 1-level transforaminal lumbar interbody fusion spine surgery on (b)(6) 2020 which consisted of seaspine's reef to interbody as well as seaspine's mariner pedicle screw system.A revision surgery occurred on (b)(6) 2021 due to three mariner screws that fractured in the postoperative period.The surgeon was able to successfully remove two of the screws and one remains implanted.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SOLID SCREW 6.50 X 50MM
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 13018505
• Report Number: 3012120772-2021-00089
• Device Sequence Number: 5127393
• Product Code: NKB
• UDI-Device Identifier: 10889981068257
• UDI-Public: 10889981068257
• 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: 2020
• Device Explanted Year: 2021
• 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): 12/16/2021

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: 41-6550-1
• Device Catalogue Number: 41-6550-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REEF TO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male