FDA Adverse Event Malfunction Summary report: N

KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE

MDR report key: 21924497 · Received April 29, 2025

Report

Report Number: 6000033-2025-00037
Event Type: Malfunction
Date Received: April 29, 2025
Date of Event: April 7, 2025
Report Date: April 29, 2025
Manufacturer: CARDIAC SURGERY MFG KERKRADE
Product Code: NDN
PMA / PMN Number: SEE H11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

G2: COUNTRY OF ORIGIN IS INDIA. G3: THE REPORTED PRODUCT C05B IS NOT MARKETED IN US BUT A SIMILAR PRODUCT WITH PRODUCT ID: CX01A, UDI: (B)(4) WITH 510(K)# K102397 IS MARKETED IN US. 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 A USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BONE CEMENT WAS IDENTIFIED AS FAULTY BEFORE USE. THE BONE CEMENT WAS IDENTIFIED AS FAULTY BEFORE USE BECAUSE THE MONOMER CRYSTALIZED. THE PRODUCT WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
503830	KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE	CEMENT, BONE, VERTEBROPLASTY	NDN	CARDIAC SURGERY MFG KERKRADE	C05B	227619011

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown