FDA Adverse Event Malfunction Summary report: N

ZEVO CERVICAL PLATE SYSTEM

MDR report key: 23206813 · Received October 3, 2025

Report

Report Number: 3003120897-2025-00307
Event Type: Malfunction
Date Received: October 3, 2025
Date of Event: August 19, 2025
Report Date: October 3, 2025
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: HXX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H3: PRODUCT ANALYSIS OF PART # 3030007, LOT # K24L1424 - VISUAL AND OPTICAL INSPECTION CONFIRMED THE T8 PORTION OF THE DRIVER HAS BROKEN. THE DAMAGE TO THE DRIVER APPEARS TO BE FROM 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 DRIVER WAS STRIPPED AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
292455	ZEVO CERVICAL PLATE SYSTEM	SCREWDRIVER	HXX	MEDTRONIC SOFAMOR DANEK USA, INC.	3030007	K24L1424

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown