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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY

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MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number CX01A
Device Problems Product Quality Problem (1506); Chemical Problem (2893)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during a kyphoplasty procedure in a patient diagnosed with metastic bone tumor. It was reported that the cement was setting too fast.  the cement was so thick at 30 seconds we could barely fill 6 bone filers. The cement was mixed for 30 secs and it was stored at proper temperature. The cement was used on the patient and the procedure was completed successfully. There will be no product return and no patient injury / complication was reported.
 
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Brand NameKYPHX HV-R BONE CEMENT
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key11573569
MDR Text Key246084150
Report Number1030489-2021-00408
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCX01A
Device Catalogue NumberCX01A
Device Lot NumberEL70200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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