FDA Adverse Event Malfunction Summary report: N

ZEVO CERVICAL PLATE SYSTEM

MDR report key: 21489456 · Received February 28, 2025

Report

Report Number: 1030489-2025-01046
Event Type: Malfunction
Date Received: February 28, 2025
Date of Event: November 12, 2024
Report Date: February 28, 2025
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: HXX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H3: PRODUCT ANALYSIS OF PART # 3030007 ; LOT # IM15D007 VISUAL AND OPTICAL INSPECTION CONFIRMED THE TIP OF THE DRIVER HAS BROKEN. THE DAMAGE TO THE TIP OF THE DRIVER IS CONSISTENT WITH TORSIONAL OVERLOAD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE DRIVERS WERE STRIPPED. THE REPORTED PRODUCT WAS USED SUCCESSFULLY ON PRIOR SURGERIES. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
648762	ZEVO CERVICAL PLATE SYSTEM	SCREWDRIVER	HXX	MEDTRONIC SOFAMOR DANEK USA, INC	3030007	IM15D007

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown