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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 KE152
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product was not 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 kyphoplasty surgery due to osteoporotic compression fracture at l1-l2.Intra-op, balloon ruptured at low pressure (160psi) in soft bone well below specified limits.There were no patient symptoms or complications as a 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 Key8797437
Report Number9612164-2019-02896
Device Sequence Number16221030
Product Code HRX
UDI-Device Identifier00763000025656
UDI-Public00763000025656
Combination Product (Y/N)N
Initial Reporter StateMA
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) 07/17/2019
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 Expiration Date04/24/2021
Device Catalogue NumberKE152
Device Lot Number217528057
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2019
Initial Report FDA Received Date07/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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