KYPHOPAK TRAY

MDR report key: 10318716 · Received July 24, 2020

Report

Report Number: 2953769-2020-00016
Event Type: Malfunction
Date Received: July 24, 2020
Date of Event: July 16, 2020
Report Date: July 24, 2020
Manufacturer: MDT KYPHON NEUCHATEL MFG
Product Code: LXH
PMA / PMN Number: K041454
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REPORT SOURCE: FOREIGN: (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH COMPRESSION FRACTURE FOR SPINAL THERAPY. IT WAS AN INTRA-OP EVENT. IT WAS REPORTED THAT IBT FAILED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY BECAUSE THERE WAS A HOLE IN THE BALLOON AND CONTRAST MEDIA LEAKED INTO THE VERTEBRAL BODY. RAPTURE OCCURRED DURING INFLATION. PRESSURE WAS 100. VOLUME PRIOR TO RUPTURE WAS 2ML. IT WAS CONFIRMED THAT THERE WAS NO ISSUE WITH IBT. THERE WAS A DELAY IN OVERALL PROCEDURE. LESS THAN 60 MINS. NO FRAGMENTS OF BALLOON LEFT IN PATIENT. PATIENT NOT ALLERGIC TO CONTRAST MEDIA. IT WAS CLEANED WITH SALINE VIA OSTEO INTRODUCER NO FURTHER PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE: 2020-JUL-21; THERAPY USED WAS PERCUTANEOUS VERTEBROPLASTY TO TREAT OVF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
783168	KYPHOPAK TRAY	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	MDT KYPHON NEUCHATEL MFG	KPT1502	219947526

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR