MAUDE Adverse Event Report: RENOVIS SURGICAL TECHNOLOGIES, INC. S100; STRAIGHT ROD 5.5MM DIAMETER 480MM LENGTH TI6AL4V

Model Number S100

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

The information was received in writing.The complaint was concerning the ti alloy dia 5.5mm rod, l480 mm rod for the s100 pedicle screw system, renovis part# 1101-053-480, lot# 1476-11.Per the received documentation the surgery took place (b)(6) 2014, one rod was fractured by (b)(6) 2015, and both rods were fractured by (b)(6) 2015.Dr.(b)(6) performed revision surgery on (b)(6) 2015.Per a phone conversation with the sales rep (ac) on (b)(6) 2017, the pedicle screws utilized in the original procedure were not manufactured by renovis surgical technologies.The renovis s100 ifu# 4101-001 states the following in the general conditions of use section: the s 100 pedicle screw system should not be used in conjunction with components from a different source, a different manufacturer, or made of a different material.The fractured rods have not been returned to renovis.Without x-ray images and/or the explanted rods, the cause of the failed rods cannot be determined.

Event Description

On (b)(6) 2017 renovis surgical technologies customer service (kj) was notified of a complaint that 2 titanium rods used in a spinal fusion surgery had fractured and revision surgery had been performed to replace the fractured rods.

• Brand Name: S100
• Type of Device: STRAIGHT ROD 5.5MM DIAMETER 480MM LENGTH TI6AL4V
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES, INC.; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• Manufacturer (Section G): RENOVIS SURGICAL TECHNOLOGIES, INC.; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• Manufacturer Contact: rachelle heminger ; 1901 w. lugonia ave.; suite 340; redlands, CA 92374
• MDR Report Key: 6486976
• MDR Text Key: 72620790
• Report Number: 3007932279-2017-00002
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00841523106974
• UDI-Public: 00841523106974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: S100
• Device Catalogue Number: 1101-053-480
• Device Lot Number: 1476-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• 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