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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHOPAK¿ TRAY ARTHROSCOPE

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MEDTRONIC SOFAMOR DANEK USA, INC KYPHOPAK¿ TRAY ARTHROSCOPE Back to Search Results
Model Number KPT1002
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare provider via the manufacturer representative regarding an event which occurred during a l5 bkp procedure. It was reported that the contrast media did not pass well. Event occurred that it was managed to inflate the balloon, but the balloon did not deflate, and ibt was cut and removed.  the pressure was unknown, but bone was not specially hardened (curette was not used).  in addition, there was no particular problem during the preparation.  after the operation, there was resistance when attempting to move the handle of inflation syringe with the cut ibt connected.  it was said that from the sales rep's point of view, there was a feeling that something was stuck at the bifurcated part of ibt. No patient injury was reported.
 
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Brand NameKYPHOPAK¿ TRAY
Type of DeviceARTHROSCOPE
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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key12090208
MDR Text Key259364831
Report Number1030489-2021-00864
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKPT1002
Device Catalogue NumberKPT1002
Device Lot Number221952899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
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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