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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE
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MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE Back to Search Results
Catalog Number K09A
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/02/2019
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.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Pre-operative diagnosis: primary osteoporosis type of fracture: compression fracture levels implanted: t12 it was reported that intra-op, the balloon ruptured during inflation.The procedure was however completed with the same product.It is unknown if there were any patient complications due to this event.
 
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Brand Name
KYPHON XPANDER INFLATABLE BONE TAMP
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key8952935
Report Number9612164-2019-03674
Device Sequence Number2041567
Product Code HRX
UDI-Device Identifier00763000025595
UDI-Public00763000025595
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 Physician
Type of Report Initial
Report Date (Section B) 09/01/2019
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 NumberK09A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2019
Initial Report FDA Received Date09/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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