KYPHX INFLATABLE BONE TAMP

MDR report key: 1674972 · Received May 4, 2010

Report

Report Number: 2953769-2010-00178
Event Type: Injury
Date Received: May 4, 2010
Date of Event: January 1, 2008
Report Date: April 5, 2010
Manufacturer: MEDTRONIC SPINE LLC.
Product Code: HXG
PMA / PMN Number: K981251
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AK, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

METHOD - DEVICE NOT RETURNED, FOLLOW UP WITH COMPANY REPRESENTATIVE.

Description of Event or Problem · 1

DURING A PHYSICIAN REVIEW OF THE OPERATIVE REPORT OF A MULTI LEVEL KYPHOPLASTY CASE THAT OCCURRED IN (B) (6), IT WAS REPORTED THAT THE BONE "CEMENT WAS NOTED ALL UP AND DOWN THE CANAL". IT WAS STATED IN THE REPORT THAT THE PHYSICIAN COULD NOT SEE VERY WELL, HOWEVER, STILL CONTINUED WITH THE PROCEDURE; AND THE BONE CEMENT REACHED TOOTHPASTE CONSISTENCY PRIOR TO INJECTION. IT WAS ALSO NOTED THAT A DRILL WAS PUT THROUGH THE ANTERIOR CORTEX OF THE VERTEBRAL BODY, AND BASED ON A CT IMAGE, THERE IS A CLEAR TRACT THROUGH THE CANAL THE SAME SIZE AS THE CANULA. REPORTEDLY, THE BALLOON ALSO RUPTURED AND THE CONTRAST TRAVELED EVERYWHERE. IT IS UNKNOWN IF ANY BALLOON FRAGMENTS WERE LEFT IN THE PATIENT OR IF THERE WAS ANY ALLERGY TO THE CONTRAST MEDIA. THE PATIENT WAS PARALYZED. IT WAS CONFIRMED THAT THE BONE CEMENT EXTRAVASATION WAS REPORTED IN MFR REPORT# 2953769-2009-00202 AND FILED ON 12/18/2009. NO ADDITIONAL INFORMATION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KYPHX INFLATABLE BONE TAMP	INFLATABLE BONE TAMP	HXG	MEDTRONIC SPINE LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK