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

Device Problem Positioning Failure (1158)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Seaspine was made aware of this event on 30 mar 2021.At this time, no explants have been made available for investigation.The surgeon will continue to monitor the patient's recovery for any indication necessitating additional treatment.Review of labeling: possible adverse events: -pain, discomfort, or abnormal sensations due to the presence of the device -postoperative fracture due to trauma, defects, or poor bone stock.

Event Description

The patient underwent t6-pelvis spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system.The patient noted a considerable fall after their six month postoperative follow up appointment, and experienced pain directly over the posterior iliac area into the hip and thigh, as well as global weakness.A ct showed perforation of the tip of the left iliac screw through the outer table of the ilium.The surgeon elected to revise the construct and remove the left iliac screw and transverse connector.In a postoperative follow up appointment on (b)(6) 2021, the patient reported significant reduction of pain in the region.The surgeon continues to monitor the patient's recovery for any indication necessitating additional treatment.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: ILIAC 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: macy nicol ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165137
• MDR Report Key: 11742340
• MDR Text Key: 250245273
• Report Number: 3012120772-2021-00032
• 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: study,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention