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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON EXPRESS II INFLATABLE BONE TAMP; ARTHROSCOPE
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MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON EXPRESS II INFLATABLE BONE TAMP; ARTHROSCOPE Back to Search Results
Catalog Number KE102
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/20/2018
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 the patient was pre-operatively diagnosed with compression fracture and underwent balloon kyphoplasty (bkp) surgery.During surgery, the inflated balloon tamp (ibt) ruptured while inflating at 400psi.The product came in contact with the patient.No patient complications were reported.
 
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Brand Name
KYPHON EXPRESS II INFLATABLE BONE TAMP
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L DE C.V.
avenida paseo cucapah # 10510
parque industrial ei lago
tijuana,bc 22570
MX  22570
MDR Report Key8251637
Report Number9612164-2019-00198
Device Sequence Number16546023
Product Code HRX
UDI-Device Identifier00763000025632
UDI-Public00763000025632
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
K123771
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/15/2019
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 NumberKE102
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/20/2018
Initial Report FDA Received Date01/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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