FDA Adverse Event Malfunction Summary report: N

BKP BALLOONS

MDR report key: 11691684 · Received April 20, 2021

Report

Report Number: 1030489-2021-00508
Event Type: Malfunction
Date Received: April 20, 2021
Date of Event: March 1, 2017
Report Date: April 20, 2021
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: HXG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

REPORT SOURCE: (B)(6). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA SAFETY AGGREGATED REPORT REGARDING THE PATIENTS WITH AN INDICATION OF TIBIA PLATEAU FRACTURES IN NEED OF BALLOON KYPHOPLASTY USED IN SPINAL THERAPY. IN A CLINICAL SURVEY TITLED AGGREGATE DATA COLLECTION ON EXTREMITIES: TIBIA PLATEAU AND CALCANEUS FRACTURES WITH PRODUCT KYPHON XPANDER (TM) II INFLATABLE BONE TAMPS SYSTEM, IT WAS REPORTED THAT THERE WERE TOTAL OF 2 ADVERSE EVENT FROM THE SURGERIES THAT TOOK PLACE BETWEEN (B)(6) 2017 TO (B)(6) 2020. THERE WAS ONE INSTRUMENT MALFUNCTION/ BREAKAGE AND LOSS OF CORRECTION IN 1 PATIENT REPORTED. THE DEVICE FAILURE OCCURRED INTRA-OP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE EVENT LOSS OF CORRECTION IN 1 PATIENT IS UNLIKELY TO BE RELATED TO PROCEDURE AND DEVICE. THERE WAS NO RELATION TO EVENT WITH THE CEMENT. SO, SECOND PROCEDURE WAS PERFORMED IN PATIENT WITH LOSS OF CORRECTION REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
591866	BKP BALLOONS	TAMP	HXG	MEDTRONIC SOFAMOR DANEK USA, INC	KY_UNK_BKP_IBT	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1