FDA Adverse Event Malfunction Summary report: N

KYPHX HV-R BONE CEMENT

MDR report key: 1619624 · Received February 26, 2010

Report

Report Number: 2953769-2010-00086
Event Type: Malfunction
Date Received: February 26, 2010
Date of Event: December 22, 2007
Report Date: July 21, 2008
Manufacturer: MEDTRONIC SPINE LLC.
Product Code: NDN
PMA / PMN Number: K033801
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REPORT SOURCE: ARTICLE TITLED: "SHORT SEGMENT PEDICLE SCREW INSTRUMENTATION AND AUGMENTATION VERTEBROPLASTY IN LUMBAR BURST FRACTURES: AN EXPERIENCE" BY SUHAIL AFZAL, SALEEM AKBAR, SHABIR A. DHAR, PER PUBLISHED IN EUR SPINE J DOI 10.1007/S00586-008-0587. METHOD: DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

Description of Event or Problem · 1

IN AN ARTICLE TITLED, "SHORT SEGMENT PEDICLE SCREW INSTRUMENTATION AND AUGMENTATION VERTEBROPLASTY IN LUMBAR BURST FRACTURES: AN EXPERIENCE ", THE FOLLOWING EVENTS WERE REPORTED: TWO PTS HAD CEMENT LEAKAGE IN THE SPINAL CANAL. THE SPINAL CANAL WAS CLEARED OF THE PMMA IMMEDIATELY AND THOROUGHLY WASHED WITH SALINE. ONE PT HAD CEMENT LEAKAGE IN THE CAUDAL DISC SPACE. ONE PT HAD SUPERFICIAL WOUND INFECTION, WHICH WAS OBSERVED THIRD POST OPERATIVE, THAT RESOLVED WITH ANTIBIOTICS AND DAILY DRESSING CHANGES. THE CEMENT LEAKAGES WERE NOTICED DURING SURGERY AND THUS LIMITED THE FURTHER INJECTION OF PMM IN THESE CASES. ALL PTS RECOVERED UNEVENTFULLY, AND THE NEUROLOGIC EXAMINATION REVEALED NO DEFICITS. 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	37 YR