MAUDE Adverse Event Report: SPINAL ELEMENTS, INC SAVANNAH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The original surgery was 7 years ago.Allegedly there is pseudarthrosis, but no further surgical information was given.Dhr review cannot be completed as no device information has been received.No evaluation of the device can be performed, as the device was not returned.Unknown factors include: exact implant duration, patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort.Root cause or specific failure mode cannot be determined.Labeling review notes: "warnings: devices are not intended to be the sole means of spinal support.Use of these products without a bone graft or in cases that develop into a non-union will not be successful.No spinal implant can withstand body loads without the support of bone.In this event, bending, loosening, disassembly and/or breakage of the device(s) will occur.

Event Description

Reportedly a patient received intervertebral body fusion procedure with posterior fixtation (l2-l3) in 2013.On (b)(6) 2020 it was reported that the left l3 pedicle bone screw fractured as a result of non-union/pseudarthrosis.Revision surgery is planned.No further event details were given.Patient status is unknown.

• Brand Name: SAVANNAH
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 11037877
• MDR Text Key: 222408090
• Report Number: 3004893332-2020-00015
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/18/2020
• 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
• Patient Outcome(s): Required Intervention