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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 K15A
Device Problem Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/08/2016
Event Type  Injury  
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.
 
Event Description
Patient demographics: initials-(b)(6), gender-male, age at the time of event: (b)(6) years. Pre-op diagnosis: l2 compression fracture. Levels implanted: l2. It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty for compression fracture at l2. Physician was taking the balloon out of the vertebral body after deflating the balloon. The balloon ruptured with the markers staying inside of the patients vertebral body and detaching from the device. Physician then injected cement into the body completing the kyphoplasty leaving the remainder of the balloon with the radiopaque markers inside of two per body. It was unknown if there were any adverse affects on the patient.
 
Manufacturer Narrative
Additional information: x-ray review: fractured implants of kyphoplasty balloon are visible in post/ intra-op x-rays provided. If balloon is over inflated it can ruptured or it can be sheared off against pak needle if not completely deflated before withdrawal. Root cause: surgical technique. 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.
 
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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 Key5999234
MDR Text Key106169197
Report Number2953769-2016-00077
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,Followup
Report Date 11/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2018
Device Catalogue NumberK15A
Device Lot Number0008067673
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 Received11/22/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/25/2016
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: 10/05/2016 Patient Sequence Number: 1
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