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

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.

• Brand Name: KYPHOPAK¿ TRAY
• Type of Device: ARTHROSCOPE
• 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 Key: 12090208
• MDR Text Key: 259364831
• Report Number: 1030489-2021-00864
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• 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 Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: KPT1002
• Device Catalogue Number: KPT1002
• Device Lot Number: 221952899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• 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