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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 K15A
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/07/2019
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 a surgery due to vertebral compression fracture.Intra-op, ibt ruptured during procedure.Ibt ruptured at 285 psi.There was no resistance and balloon pressure kept coming down when inflated.No patient symptoms or complications were reported as a result of this event.
 
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Brand Name
ARTHROSCOPE
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo cucapah # 10510
parque industrial ei lago
tijuana,bc 22570
MX  22570
MDR Report Key8949234
Report Number9612164-2019-03661
Device Sequence Number2471602
Product Code HRX
UDI-Device Identifier00858196001185
UDI-Public00858196001185
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
K041454
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) 08/30/2019
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 NumberK15A
Device Lot Number217445103
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2019
Initial Report FDA Received Date08/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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