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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-J
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Stenosis (2263); No Code Available (3191)
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).This part is not approved for use in the united states; however, the catalog # c01a and 510k # k041584 of 'like devices' was cleared in the united states.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
It was reported that a patient underwent balloon kyphoplasty procedure (bkp) at l3 to treat vertebral compression fracture.The patient's anterior longitudinal ligament was "connected" at levels th11-l2 due to diffused idiopathic skeletal hyperostosis (dish).Post-op, it was reported that on (b)(6) 2015, the patient developed lower extremity pain due to vertebral collapse of l3 and stenosis led by cement migration in the vertebrae.On (b)(6) 2015, patient underwent revision surgery to perform decompression at l3 and posterior fixation at levels 3-above 2-below.Patient's post-revision course was well.Surgeon commented that cranial levels that suffered dish might have pulled cranial endplate of l3 and fracture at the endplate was occurred that resulted the cement migration.He also commented that bkp for the patient who had dish was "difficult" but thought the revision recovered the situation.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5179338
MDR Text Key29292333
Report Number2953769-2015-00144
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Report Date 09/29/2015
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-J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/27/2015
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
Patient Outcome(s) Required Intervention;
Patient Age00085 YR
Patient Weight41
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