FDA Adverse Event Malfunction Summary report: N

KYPHON EXPRESS II INFLATABLE BONE TAMP

MDR report key: 7174424 · Received January 9, 2018

Report

Report Number: 2953769-2018-00003
Event Type: Malfunction
Date Received: January 9, 2018
Date of Event: December 11, 2017
Report Date: May 4, 2018
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: HRX
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE INFLATABLE BONE TAMP BALLOON IDENTIFIED A SHARP CUT AT THE DISTAL LOBE OF THE BALLOON. THE MORPHOLOGY, LOCATION AND TIMING OF THE BALLOON RUPTURE IS CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT, SUCH AS BONE SPLINTERS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# KE152, 510K# K123771 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION; THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY PROCEDURE DUE TO OSTEOPOROTIC FRACTURE AT TH8. INTRA-OPERATIVELY, THE INFLATABLE BONE TAMP (IBT) RUPTURED DURING INFLATION. THE IBT FAILED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
19037	KYPHON EXPRESS II INFLATABLE BONE TAMP	ARTHROSCOPE	HRX	MEDTRONIC SOFAMOR DANEK USA, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR