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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO ARTHROSCOPE
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MEDTRONIC MEXICO ARTHROSCOPE Back to Search Results
Catalog Number KX203
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/09/2019
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
It was reported that the patient underwent balloon kyphoplasty (bkp) at t12.Intra-op, the balloon ruptured.Balloon was inflated at a low pressure.No patient symptoms or complication were reported as result of this event.
 
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Brand Name
ARTHROSCOPE
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key8763702
Report Number9612164-2019-02708
Device Sequence Number11393879
Product Code HRX
UDI-Device Identifier00643169093676
UDI-Public00643169093676
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K101864
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/05/2019
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 NumberKX203
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/05/2019
Initial Report FDA Received Date07/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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