FDA Adverse Event Malfunction Summary report: N

KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP

MDR report key: 7676714 · Received July 11, 2018

Report

Report Number: 1030489-2018-00975
Event Type: Malfunction
Date Received: July 11, 2018
Date of Event: June 15, 2018
Report Date: October 16, 2018
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: HRX
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS: THERE IS A RADIAL RUPTURE NEAR PROXIMAL BOND PEEK. THIS TYPE OF RUPTURE IS CONSISTENT WITH DAMAGE IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

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. H6: 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 WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE(VCF) AND WAS IMPLANTED AT 2 LEVELS. DURING SURGERY, THE BALLOON RUPTURED AT ABOUT 100 PSI AND 0.5 VOLUME WHEN THE SURGEON WAS TRYING TO INFLATE IT IN THE FIRST VERTEBRAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
522088	KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP	ARTHROSCOPE	HRX	MEDTRONIC SOFAMOR DANEK USA, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1