FDA Adverse Event Malfunction Summary report: N

METRX II

MDR report key: 24892474 · Received April 16, 2026

Report

Report Number: 3003120897-2026-00709
Event Type: Malfunction
Date Received: April 16, 2026
Date of Event: March 15, 2026
Report Date: April 16, 2026
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Product Code: LXH
UDI-DI: 00673978085456
PMA / PMN Number: K993021
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H3: PRODUCT ANALYSIS OF PRODUCT ID#9560101 AND LOT NO#1903144. DURING THE ACCEPTANCE INSPECTION, IT WAS OBSERVED THAT THE IMAGE WAS CLOUDY. 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 RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN ENDOSCOPE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT BLACK SPOTS WERE SEEN ON IT. THERE WAS NO PATIENT INFORMATION AVAILABLE. THERE WERE NO FURTHER COMPLICATIONS PRESENT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE BLACK SPOTS OCCURRED ON THE LENS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
577694	METRX II	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	MEDTRONIC SOFAMOR DANEK USA, INC.	9560101	1903144	00673978085456

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown