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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 Device Embedded In Tissue or Plaque (3165)
Event Date 11/21/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
X-ray review: post op kyphoplasty images for l4/5 kyphoplasty provided. Balloon markers are present in l5 owing to balloon rupture. No information is provided about expansion pressure. Balloon can be ruptured if over inflated past instructions for use(ifu) recommended pressure or if pulled back against "pac" needle. Root cause: surgical technique.
 
Event Description
It was reported that on (b)(6) 2016 the patient underwent kyphoplasty at l-5. Intra-op, the balloon popped during inflation. While pulling the balloon out, some part of it remained inside the vertebral body. No patient complications were reported.
 
Manufacturer Narrative
Product analysis:the reported complaint of a balloon rupture was confirmed during product evaluation. A radial tear was observed near the proximal peak of the balloon. This observation is consistent with rupture due to contact with bone splinters during instrument usage. Due to the ¿umbrella¿ effect of the radially cut ibt, the ibt was unable to be collapsed and removed from the stylus. The above observations are consistent with intraoperative instrument damage.
 
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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 Key6184482
MDR Text Key106169081
Report Number2953769-2016-00089
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,Followup,Followup
Report Date 01/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK15B
Device Lot Number0007856652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
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

Patient Treatment Data
Date Received: 12/18/2016 Patient Sequence Number: 1
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