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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC BALLOON KYPHOPLASTY ESSENTIALS KIT; ARTHROSCOPE
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MEDTRONIC SOFAMOR DANEK USA, INC BALLOON KYPHOPLASTY ESSENTIALS KIT; ARTHROSCOPE Back to Search Results
Catalog Number NH152PB-CDS
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/25/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
 
Event or Problem Description
It was reported that patient underwent balloon kyphoplasty.Intra-op, balloon ruptured upon inflation at only 200 psi and 1.5 ccs of volume.Patient was not allergic to contrast medium.No patient complications were reported as a result of this event.
 
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Brand Name
BALLOON KYPHOPLASTY ESSENTIALS KIT
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key6806662
Report Number1030489-2017-01930
Device Sequence Number139281
Product Code HRX
UDI-Device Identifier00643169703599
UDI-Public00643169703599
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K151532
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/27/2018
Device Catalogue NumberNH152PB-CDS
Device Lot NumberWI492094
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2017
Initial Report FDA Received Date08/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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