FDA Adverse Event Malfunction Summary report: N

KYPHX HV-R BONE CEMENT

MDR report key: 1823739 · Received August 26, 2010

Report

Report Number: 2953769-2010-00356
Event Type: Malfunction
Date Received: August 26, 2010
Date of Event: December 5, 2009
Report Date: August 4, 2010
Manufacturer: MEDTRONIC SPINE LLC
Product Code: NDN
PMA / PMN Number: K041584
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REPORT SOURCE: ARTICLE TITLED "A COMPARATIVE ANALYSIS OF THE RESULTS OF VERTEBROPLASTY AND KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", BY KRISHNA KUMAR, MB, MS, RITA NGUYEN, BSC, SHARON BISHOP, BNURS, MHSCI. THE ARTICLE DID NOT INDICATE THAT THE BONE CEMENT USED IN THIS STUDY IS KYPHX HV-R BONE CEMENT. METHOD - DEVICE NOT RETURNED; FOLLOWED-UP WITH AUTHOR. REFERENCE MFR REPORT #: 2953769-2010-00354 - 2953769-2010-00370.

Description of Event or Problem · 1

IN AN ARTICLE TITLED "A COMPARATIVE ANALYSIS OF THE RESULTS OF VERTEBROPLASTY AND KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", A PROSPECTIVE STUDY OF 28 VERTEBROPLASTY PATIENTS AND 24 KYPHOPLASTY PATIENTS TREATED OVER THE PAST 2 YEARS WAS PRESENTED. THE FOLLOWING EVENT WAS REPORTED: THE PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE USING A BIPEDICULAR APPROACH AT LEVEL T9. CEMENT EXTRAVASATION OCCURRED. THE CEMENT EXTRAVASATION OCCURRED INTO THE INTRADISCAL SPACE, ANTERIOR TO THE VERTEBRAL BODY, ALONG THE NERVE ROOT, AND INTO THE SPINAL CANAL. THERE WERE NO NEUROLOGICAL DEFICIT REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KYPHX HV-R BONE CEMENT	HIGH VISCOSITY, RADIOPAQUE BONE CEMENT	NDN	MEDTRONIC SPINE LLC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR