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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE
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KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE Back to Search Results
Model Number KEX152EB-CDS-A
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/14/2021
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
Information was received from healthcare professional via manufacturer representative regarding a patient having kyphoplasty due to vertebral compression fracture.It was reported that balloon ruptured during inflation.There were no patient symptoms/ complications as a result of the event.
 
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Brand Name
KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
Common Device Name
ARTHROSCOPE
MDR Report Key12710239
Report Number1030489-2021-01322
Device Sequence Number4240139
Product Code HRX
UDI-Device Identifier00763000557096
UDI-Public00763000557096
Combination Product (Y/N)N
Initial Reporter StateMD
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) 10/28/2021
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 Date06/28/2022
Device Model NumberKEX152EB-CDS-A
Device Catalogue NumberKEX152EB-CDS-A
Device Lot Number0222980345
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2021
Initial Report FDA Received Date10/28/2021
Date Device Manufactured09/23/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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