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U.S. Department of Health and Human Services

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

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MDT KYPHON NEUCHATEL MFG KYPHON XPANDER¿ INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Catalog Number K13A
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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. 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 th12 for compression fracture due to primary osteoporo sis. Intra-op, the balloon was inflated slightly despite application of pressure due to hard bone. The surgeon stopped the inflating and injected cement in the vertebral body. The breakage of the balloon was suspected because balloon's shape was distorted during checking the balloon laterally. When the balloon was inflated outside the operative field, it was found that there was small hole on it. No contract agent remained in the vertebral body. After the event, the surgery was finished as usual. Product came in contact with the patient. No patient complications were reported.
 
Manufacturer Narrative
Product analysis: "functional examination of the ibt balloon identified a small pinhole puncture near the distal peak of the balloon. The location, nature and timing of the balloon puncture is consistent with in vivo contact with sharp object, such as bone splinters. The above observations are consistent with in vivo contact with sharp object. ".
 
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Brand NameKYPHON XPANDER¿ 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 Key6126964
MDR Text Key105920236
Report Number2953769-2016-00084
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK13A
Device Lot NumberWI441982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2017
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

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