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

Model Number	S100
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STRAIGHT ROD 5.5MM DIAMETER 480MM LENGTH TI6AL4V
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES, INC.; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• MDR Report Key: 6486976
• Report Number: 3007932279-2017-00002
• Device Sequence Number: 13775337
• Product Code: KWP
• UDI-Device Identifier: 00841523106974
• UDI-Public: 00841523106974
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K101682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 04/06/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention