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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE
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MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE Back to Search Results
Catalog Number K09A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/02/2018
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.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that intra-op, the balloon ruptured during inflation.The product came in contact with the patient.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KYPHON XPANDER INFLATABLE BONE TAMP
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key7705144
Report Number1030489-2018-01038
Device Sequence Number1329496
Product Code HRX
UDI-Device Identifier00613994703996
UDI-Public00613994703996
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K041454
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/04/2018
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 NumberK09A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/20/2018
Supplement Date Received by Manufacturer08/08/2018
Initial Report FDA Received Date07/19/2018
Supplement Report FDA Received Date10/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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