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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
Model Number C01A-J
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
This product is not approved for sale in us but a similar device with catalog# c01a, 510k #k041584 and udi: (b)(4) is approved for sale in us.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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via a field contact regarding a patient undergoing a spinal therapy.It was reported that after being fixed with a mixer, the cement hardened early and could not be filled in bfd.Another kit was opened.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product was discarded and will not be replaced.Device status reason : never implanted there was no patient involved in this event and so, it did not come in contact with the patient.Procedure/therapy: bkp.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
Information was received from a healthcare professional via a field contact regarding a patient undergoing a spinal therapy.It was reported that after being fixed with a mixer, the cement hardened early and could not be filled in bfd.Another kit was opened.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product was discarded and will not be replaced.Device status reason : never implanted there was no patient involved in this event and so, it did not come in contact with the patient.Procedure/therapy: bkp additional information received.The event involves a patient but the product did not come in contact with the patient.
 
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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 2000
SZ  2000
MDR Report Key11601133
MDR Text Key245531179
Report Number2953769-2021-00014
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC01A-J
Device Catalogue NumberC01A-J
Device Lot NumberEL70129
Was Device Available for Evaluation? No
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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