MAUDE Adverse Event Report: RENOVIS SURGICAL TECHNOLOGIES, INC. S 150 STAND-ALONE ANTERIOR CERVICAL INTERBODY FUSION; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	S 150
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was reported to renovis after a routine 6-month follow-up examination.And x-ray revealed a dislodged cover plate and two backed-out screws.According to the surgeon, the patient is asymptomatic and the affected level of the 3 level construct have fused.There are no current plans to re-operate as the cover plate appears fully captured in the disc space.This complaint will be re-opened if/when renovis receives information that a revision surgery is planned or has been performed.As no revision surgery has been planned, renovis will not receive the implants back for a full investigation.Based on the initial analysis, the most likely cause for the failure mechanism is one or both of the outboard screws pushing on and dislodging the cover plate due to excessive forces placed on the most inferior cage of a 3 level fusion.Device not explanted.
Event or Problem Description
Sales rep for s1 spine (gl) informed renovis customer service (kj) of a product complaint on 02/23/2017.The complaint pertains to a s150 stand-alone anterior cervical interbody fusion 3-level construct, which is a contraindication to the ifu.The complaint was reported to renovis after a routine 6-month follow-up examination.An x-ray revealed a dislodged cover plate and two backed-out screws on the most inferior cage of a 3-level fusion.According to the surgeon, the patient is asymptomatic and all 3 levels have fused.There are no current plans to re-operate as the cover plate appears fully captured in the disc space.

• Brand Name: S 150 STAND-ALONE ANTERIOR CERVICAL INTERBODY FUSION
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES, INC.; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• MDR Report Key: 6426074
• Report Number: 3007932279-2017-00001
• Device Sequence Number: 783340
• Product Code: OVE
• UDI-Device Identifier: 00841523118250
• UDI-Public: 00841523118250
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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: No Information
• Device Expiration Date: 01/29/2021
• Device Model Number: S 150
• Device Catalogue Number: 1055-161-306
• Device Lot Number: 3296-8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1