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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHX® HV-R? BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

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MDT KYPHON NEUCHATEL MFG KYPHX® HV-R? BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number C01A
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Embolism (1829)
Event Date 10/29/2014
Event Type  Injury  
Event Description
It was reported that a three level uni-pedicular kyphoplasty was performed on a myeloma patient for vcf (vertebral compression fractures).A ct scan was ordered to see how the tumor was effected in the three vertebral bodies.Upon review of ct, three emboli were discovered apparently from cement migration.Two were present in the lungs and one in the heart.During the procedure, no apparent extravasation was observed.The pulmonary emboli and the cardiac emboli were discovered from the post-op ct scan.Patient is currently asymptomatic according to surgeon.The patient will potentially need to undergo cardiac surgery but has not been confirmed at this time.According to the report, the cement was mixed for 90 seconds with a mixer and the ifu (instructions for use) were followed during the procedure.The viscosity of the cement was reported as "doughy and homogenous" prior to delivery into the patient and storage conditions for the cement were met prior to use.No further information could be obtained.
 
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.
 
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Brand Name
KYPHX® HV-R? BONE CEMENT
Type of Device
CEMENT, BONE, VERTEBROPLASTY
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
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4279450
MDR Text Key5298516
Report Number2953769-2014-00149
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC01A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2014
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BKP
Patient Outcome(s) Life Threatening;
Patient Age00048 YR
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