FDA Adverse Event Malfunction Summary report: N

NEXXT MATRIXX INTERBODY SYSTEM

MDR report key: 7984992 · Received October 19, 2018

Report

Report Number: 3007922509-2018-00001
Event Type: Malfunction
Date Received: October 19, 2018
Date of Event: May 14, 2018
Report Date: June 21, 2018
Manufacturer: NEXXT SPINE LLC
Product Code: MQP
UDI-DI: 00889929020258
PMA / PMN Number: K171140
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF MANUFACTURING HISTORY RECORDS SHOWS THE PRODUCT WAS RELEASED WITH NO ANOMALIES AND CONFORMING TO DESIGN SPECIFICATIONS. AS PART OF RISK MANAGEMENT, THE CONDITION IS ADDRESSED IN THE IFU AND SURGICAL TECHNIQUE.

Description of Event or Problem · 1

IT WAS REPORTED ON (B)(6) 2018 DURING A SPINAL PROCEDURE A MATRIXX IMPLANT FRACTURED WHILE THE SURGEON WAS TRYING TO ROTATE INTO PLACEMENT. THE SURGEON WAS PUSHING THE IMPLANT BEYOND EXPECTATION AND CAUSED AN EXTREME LOAD AND THE IMPLANT FRACTURED. IT SHOULD BE NOTED, THE TORQUE APPLIED TO THE IMPLANT WAS GREATER THAN THE DESIGN LIMIT.75% TO 80% OF THE DEVICE IS IMPLANTED IN THE DISC SPACE AND THE REMAINDER OF THE DEVICE WAS NOT IMPLANTED AS IT WAS ATTACHED TO THE INSERTING INSTRUMENT. AT NO TIME DURING THE PROCEDURE, DID A FRACTURED PIECE FALL INTO THE PATIENT'S WOUND. THE SURGEON INVESTIGATED AND FOUND THE IMPLANT TO BE SECURE AND WAS PERFORMING AS INTENDED SO IT WAS DECIDED TO LEAVE THE IMPLANT IN PLACE. THERE WAS NO PATIENT INJURY DUE TO THE EVENT. THE REMAINDER OF THE IMPLANT WAS LOST BY THE CENTRAL PROCESSING CENTER AT THE HOSTPITAL AND WILL NOT BE RETURNED TO NEXXT SPINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
823371	NEXXT MATRIXX INTERBODY SYSTEM	MATRIXX TLIF OBLIQUE	MQP	NEXXT SPINE LLC	54M-26-08-SP	NS7729A	00889929020258

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention