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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY
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MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number C01A
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Codes Extravasation (1842); No Known Impact Or Consequence To Patient (2692)
Date of Event 08/15/2019
Type of Reportable Event Malfunction
Additional 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.Information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient underwent unknown spinal procedure due to primary osteoporosis.Intra-operatively, the cement leaked to the up, down and anterior side of the vertebral body while filling the cement to the vertebral body.There were no patient complications as a result of alleged event.
 
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Brand Name
KYPHX HV-R BONE CEMENT
Common Device Name
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key9022088
Report Number1030489-2019-01015
Device Sequence Number2254616
Product Code NDN
UDI-Device Identifier00643169097865
UDI-Public00643169097865
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K041584
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberC01A
Device Lot NumberEL70110
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2019
Initial Report FDA Received Date09/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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