FDA Adverse Event Injury Summary report: N

RENAISSANCE SYSTEM

MDR report key: 6927731 · Received October 7, 2017

Report

Report Number: 3005075696-2017-00004
Event Type: Injury
Date Received: October 7, 2017
Date of Event: August 22, 2017
Report Date: October 7, 2017
Manufacturer: MAZOR ROBOTICS LTD.
Product Code: HAW
UDI-DI: 07290109180267
PMA / PMN Number: K120812
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER DID NOT ALLEGE ANY FAILURE OF MALFUNCTION OF THE DEVICE AND NO MALFUNCTION WAS IDENTIFIED (DURING INVESTIGATION). WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

Description of Event or Problem · 1

A COMPLAINT WAS RECEIVED ON AUGUST 28, 2017, FROM (B)(6) UNIVERSITY (USA) DESCRIBING A DBS ELECTRODE PLACEMENT SURGERY THAT WAS PROLONGED BY AN ESTIMATED 2-3 HOURS. AS REPORTED, THE USER DEVIATED FROM THE SURGICAL TECHNIQUE IN 2 STEPS OF THE SURGERY: (I) OVERTIGHTENING OF THE SCREWS WHEN ATTACHING THE RBT BASE PLATFORM TO THE SKULL (RESULTED IN THEIR BREAKAGE), AND (II) THE SURGEON ATTEMPTED OF INSERT MICROELECTRODES AFTER FIXATING THE BASE PLATFORM BUT WITHOUT RESENDING THE PATIENT TO A NEW REGISTRATION CT THIS TURN OF EVENTS RESULTED IN PROLONGATION OF THE SURGERY BY ABOUT 2-3 HOURS. THE BROKEN TIPS OF THE SCREWS WERE REMOVED BY THE SURGEON. THE PATIENT WAS EVENTUALLY SENT FOR A NEW REGISTRATION CT WHICH ALLOWED FOR ACCURATE INSERTION OF THE MICROELECTRODE. ONCE THE PLATFORM WAS STABLE AND A NEW REGISTRATION CT WAS PERFORMED, THE MICROELECTRODE PLACEMENT WAS ACCURATE AS EXPECTED. THE SURGEON WAS PLEASED WITH THE FINAL OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
707278	RENAISSANCE SYSTEM	STEREOTAXIC INSTRUMENT	HAW	MAZOR ROBOTICS LTD.	TPL0038		07290109180267

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention