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

Device Problems Patient Device Interaction Problem (4001); Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

The revision surgery was completed on (b)(6) 2020 which consisted of replacing the right s2ai screw and 5 set screws (the right l5-s2ai set screws and the left s1-s2ai set screws).The root cause of this event cannot be determined at this time as no implants or x-rays were made available for analysis and no additional information surrounding the surgical technique and/or events leading up to the failure were provided.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.

Event Description

Patient (b)(6) underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system, medtronic's magnifuse dbm, and seaspine's strand dbm from levels t10-pelvis.At the patient's first postoperative visit on (b)(6) 2020, radiographs were taken and the patient was determined to have several loose mariner set screws at the bottom of the construct.Additionally, it was reported that one of the iliac screws was potentially disarticulated.The patient returned for an additional follow up visit on (b)(6) 2020 with lumbosacral pain and opted for a revision of the t10-pelvis with retightening of the set screws at the end of the construct.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: ILIAC SCREW
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 11474156
• MDR Text Key: 239453960
• Report Number: 3012120772-2021-00021
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC MAGNIFUSE DBM; SEASPINE STRAND DBM
• Patient Outcome(s): Required Intervention