FDA Adverse Event Malfunction Summary report: N

METRX II

MDR report key: 23388220 · Received October 27, 2025

Report

Report Number: 3003120897-2025-00448
Event Type: Malfunction
Date Received: October 27, 2025
Date of Event: September 5, 2025
Report Date: October 27, 2025
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: LXH
PMA / PMN Number: K993021
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H3: PRODUCT ANALYSIS OF PART # 9560101 ; LOT # 1903143 DURING THE INCOMING INSPECTION, THERE IS A BLACK AREA/PART AT THE EDGE OF THE IMAGE WAS OBSERVED. 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 REPORTED THAT, THERE IS A BLACK AREA/PART AT THE EDGE OF THE IMAGE. PROCEDURE PERFORMED WAS HERNIECTOMY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2427705	METRX II	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	MEDTRONIC SOFAMOR DANEK USA, INC.	9560101	1903143

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown