FDA Adverse Event Malfunction Summary report: N

KYPHX HV-R BONE CEMENT

MDR report key: 10250113 · Received July 9, 2020

Report

Report Number: 2953769-2020-00014
Event Type: Malfunction
Date Received: July 9, 2020
Date of Event: June 17, 2020
Report Date: July 9, 2020
Manufacturer: MDT KYPHON NEUCHATEL MFG
Product Code: NDN
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FOR OUS COUNTRY. PMA/510(K): THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# C01A, 510K#: K160983 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING INTRA-OP, THE CEMENT SOLIDIFIED TOO EARLY. IT OCCURRED WHEN BALLOON AND MIXER WERE OPENED, AFTER CEMENT MIXED AND BALLOON INFLATED. WHEN IT WAS TRIED TO INJECT THE CEMENT INTO THE BONE FILLER DEVICES, IT COULD NOT BE INJECTED. THE CEMENT WAS NOT STORED AT THE TEMPERATURE BELOW 25 DEGREES AND NOT BETWEEN 22 AND 24 DEGREES WITHIN 24 HOURS BEFORE USE. THE OPERATION WAS PERFORMED IN THE ANGIOGRAPHY ROOM AND THE ROOM TEMPERATURE WAS 26 DEGREES. ALTHOUGH THE CEMENT WAS STORED IN A COOLER BOX CONTAINING COLD INSULATOR. BONE CEMENT DID NOT COME IN CONTACT WITH THE PATIENT. A NEW BALLOON KIT AND A NEW MIXER WERE USED. THE CEMENT WAS OPENED AND MIXED FOR 30 SECOND. THEN INJECTED INTO THE BONE FILLER DEVICES. THE PROCEDURE COMPLETED WITHOUT IMPACTS OF CEMENT INJECTION INTO THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINUTE IN OVERALL PROCEDURE TIME. FURTHER THERE IS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
714863	KYPHX HV-R BONE CEMENT	CEMENT, BONE, VERTEBROPLASTY	NDN	MDT KYPHON NEUCHATEL MFG	C01A-J	EL70156

Patients

Seq	Age	Sex	Outcome	Treatment
1