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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 KE152
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis: visual and optical examination of the ibt balloon identified a sharp cut at the distal lobe of the balloon. The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty at l1 for vertebral compression fracture. Intra-op, during inflation, the ibt (inflatable bone tamp) ruptured. The ibt failed during the first insertion attempt into the vertebral body at 250 psi. The patient was not allergic to the contrast media. The procedure was completed with a new product. The product came in contact with the patient. 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)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel,ne 2000
CH 2000
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6010155
MDR Text Key105921598
Report Number2953769-2016-00078
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKE152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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