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

Model Number	MD1-100016
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent spinal surgery, which consisted of seaspine's mariner pedicle screw system from levels t12-s1.Seaspine was informed on (b)(6) 2013 that one of the screw heads and set screws separated from the construct in the postoperative period.
Additional Manufacturer Narrative
The x-ray provided confirms two set screws separated from the construct at the s1 level, which also resulted in the separation of the two rods that the set screws were holding into place.A revision surgery occurred on (b)(6) 2022.Explants were returned for evaluation.Visual inspection of the components returned revealed one of the returned screw heads was not properly locked down onto the mating shank, and was locked down into the screw head in a partially unthreaded position.Additionally, the washer within the screw heads moved out of position.No implant fractures were present.Furthermore, two rods were returned along with the screw components.Visual inspection confirmed the rods were cut; however, there are no signs of rod fracture or malfunction.The report of postoperative head/shank separation could not be confirmed; however, it was confirmed that the head was not properly locked down onto the shank.Additionally, review of the returned components confirmed the s1 set screws loosened as a result of the screw head partially locked down, not allowing for polyaxial motion, which would have prevented the rod from normalizing within the tulip, resulting in reduced fixation strength and rod/set screw separation.Review of labeling: possible adverse events: bending, disassembly, or fracture of implant and components 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.

• Brand Name: MARINER
• Common Device Name: POINTLOCK 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15566759
• Report Number: 3012120772-2022-00042
• Device Sequence Number: 19579404
• Product Code: NKB
• UDI-Device Identifier: 10889981283803
• UDI-Public: 10889981283803
• 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 Explanted Year: 2022
• 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): 10/07/2022

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: AW146793A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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