FDA Adverse Event Malfunction Summary report: N

ACTIVOS¿ BONE CEMENT

MDR report key: 20505694 · Received October 22, 2024

Report

Report Number: 1030489-2024-01343
Event Type: Malfunction
Date Received: October 22, 2024
Date of Event: September 25, 2024
Report Date: October 22, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NDN
PMA / PMN Number: SEE H11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

G2: COUNTRY OF THE EVENT IS INDIA. G4: THE SIMILAR DEVICE WITH PRODUCT# CX01A WITH 510(K)# K102397 IS MARKETED IN UNITED STATES. 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 HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L1 COMPRESSIVE FRACTURE. IT WAS REPORTED THAT WHEN SURGEON OPENED THE CEMENT BOX FOR MIXING, IT WAS FOUND THAT LIQUID IN THE BOTTLE IS SOLIDIFY CONDITION. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2280248	ACTIVOS¿ BONE CEMENT	CEMENT, BONE, VERTEBROPLASTY	NDN	MEDTRONIC SOFAMOR DANEK USA, INC	C05A	FAGJ184

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown