MAUDE Adverse Event Report: SEASPINE INC. MARINER MIS PEDICLE SCREW SYSTEM; SET SCREW

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Based on a review of the postoperative images received, both set screws implanted at s1 separated from the construct.Multiple attempts were made to gather additional information; however, the index surgery information was not provided.Additionally, seaspine is not aware of any surgical intervention that occurred as a result of the reported malfunctions.A review of labeling notes: possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis) bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain, discomfort, or abnormal sensations due to the presence of the device increased biomechanical stress on adjacent levels.Improper surgical placement of the implant causing stress shielding of the graft or fusion mass.Intraoperative fracture, or perforation of the spine.Postoperative fracture due to trauma, defects, or poor bone stock.Postoperative warnings: surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance.The patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation.The patient should be advised that implants may bend, break or loosen despite restriction in activity.The patient should be advised to avoid mechanical vibrations that may loosen the device.The patient should be advised not to smoke or consume alcohol during recovery.

Event Description

On 10 jun 2020, seaspine was made aware of two set screws that disassociated from the mariner mis pedicle screw construct during the postoperative period.Multiple attempts were made to gather additional information; however, the index surgery information was not provided.Additionally, seaspine is not aware of any surgical intervention that occurred as a result of the reported malfunctions.

• Brand Name: MARINER MIS PEDICLE SCREW SYSTEM
• Type of Device: SET SCREW
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, ca ; 2165137
• MDR Report Key: 10252492
• MDR Text Key: 218267439
• Report Number: 3012120772-2020-00052
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1