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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON® EXPRESS¿ INFLATABLE BONE TAMP ARTHROSCOPE

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MDT KYPHON NEUCHATEL MFG KYPHON® EXPRESS¿ INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Catalog Number K15B
Device Problem Material Rupture (1546)
Patient Problem Blood Loss (2597)
Event Date 02/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). (b)(4). 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.
 
Event Description
Medical history: renal cell carcinoma preoperative diagnosis: vertebral compression fracture it was reported that on (b)(6) 2016, intra-op, ibt ruptured, ibt was inflated to 350 +- psi inflated contra lateral ibt. Then ibt was adjusted again and pressure was decreased to 0 psi. Physician pulled back on inflation syringe. Excessive amount of blood was observed coming out of the cannula. Surgeon did a cut down to see if bleeding was outside of vertebral body and then applied flo seal. Patient was taken to ct scan and was confirmed no bleeding outside of vertebral body. Patient was not allergic to contrast media. Product came in contact with the patient. Patient complications were reported unknown. No patient complications were reported.
 
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Brand NameKYPHON® EXPRESS¿ INFLATABLE BONE TAMP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel,ne 2000
CH 2000
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5478958
MDR Text Key39631531
Report Number2953769-2016-00017
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/29/2016
Device Catalogue NumberK15B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2016 Patient Sequence Number: 1
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