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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KYPHON NEUCHATEL UNK XSTOP
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KYPHON NEUCHATEL UNK XSTOP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 07/05/2014
Event Type  Injury  
Event Description
It was reported in an article entitled "interspinous spacer decompression (x-stop) for lumbar spinal stenosis and degenerative disc disease: a multi-center study with a minimum 3 year follow-up." that during follow-up, 13 superficial skin infections were reported that resolved after antibiotic therapy.
 
Manufacturer Narrative
(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
UNK XSTOP
Manufacturer (Section D)
KYPHON NEUCHATEL
kyphon sarl
pierre-a-bot 97
neuchatel,ch 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 Key4024696
MDR Text Key4845639
Report Number2953769-2014-00112
Device Sequence Number1
Product Code NQO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Physician
Type of Report Initial
Report Date 08/12/2014
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2014
Initial Date FDA Received08/20/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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