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

Model Number 10-07

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

There is no evidence confirming the event or the manufacturer of the device.No 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(s) were not returned.Unknown factors include: 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.

Event Description

Reportedly patient received spinal fusion posterior fixation from l3-l5.No index surgery details were provided.Revision was planned to tighten three loose locking screws and extend construct to s1.Revision was postponed and no further surgical information or device details were provided.

• 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: 12888724
• MDR Text Key: 281406259
• Report Number: 3004893332-2021-00022
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840916101367
• UDI-Public: 00840916101367
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-07
• Device Catalogue Number: 10-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/29/2021
• 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): Required Intervention