MAUDE Adverse Event Report: RENOVIS SURGICAL TECHNOLOGIES RENOVIS; SA CERVICAL COVER PLATE, NITINOL

Catalog Number	1050-003-004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was reported after routine follow-up examination at 2 months (date of surgery: (b)(6) 2018, date of occurrence: (b)(6) 2018).An x-ray of the patient taken during the routine follow-up shows that the lower cover plate has fractured into 5 pieces.The physician stated that the patient was asymptomatic, and no revision surgery was needed due to the fractured cover plate.Using the follow-up x-ray as a guide, solidworks was used to recreate the current condition of the superior both constructs.From the recreation of the construct, the following information can be gathered about the bottom construct: surgery was performed on two levels from c3-c5.The cervical system ifu states in the indications for use that the ".System is indicated for intervertebral fusion procedures.At one level from c2-t1".For level c3-c4 the construct is oriented 2down/1up (the two lateral screws were inserted into the inferior vertebra while the center screw was inserted into the superior vertebra).For level c4-c5 the construct is oriented 2down/1up.The plate has fractured into approximately 5 pieces.The center screw has translated approximately 0.85mm.The center screw angle is shallow by approximately 17°.The screws used in the lower construct are all 14mm in length.The two 12mm screws listed in the complaint were used on the upper construct.A review of manufacturing records show there were no discrepancies or deviations for the lot of associated implants.A root cause analysis was performed and it was determined that the most likely cause for the failure mechanism is the center screw pushing on the cover plate until it fractured.This failure mechanism is identified in the core risk document for this system.Renovis will continue to monitor and trend for similar complaints.Corrective action will be taken in the future if deemed necessary.
Event or Problem Description
During a routine 2-month follow-up visit, the surgeon was reviewing patient x-rays and discovered that the cover plate on a cervical cage implant had become dislodged and fractured.The surgeon stated that the patient was asymptomatic and no revision surgery was required at that time.

• Brand Name: RENOVIS
• Common Device Name: SA CERVICAL COVER PLATE, NITINOL
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• MDR Report Key: 8204398
• Report Number: 3007932279-2018-00003
• Device Sequence Number: 1961328
• Product Code: OVE
• UDI-Device Identifier: 00841523118090
• UDI-Public: 00841523118090
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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: 01/11/2023
• Device Catalogue Number: 1050-003-004
• Device Lot Number: 100987-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1