• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MITG - TIJUANA KYPHON XPANDER¿ INFLATABLE BONE TAMP ARTHROSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MITG - TIJUANA KYPHON XPANDER¿ INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Model Number KPT1502
Device Problems Material Deformation (2976); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
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 Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l3bkp and 2a2b posterior fusion for primary osteoporosis with intravertebral cleft fracture. It was reported that it was difficult to insert ibt into osteo introducer.  an attempt was made to insert the balloon on one side into the osteo introducer, but the balloon didn't enter.  before the insertion, the white cover of the balloon was not removed according to the surgical technique.  an attempt was made to check the lubricant of the balloon outside the operative field, but they could not judge the presence or absence of the  lubricant because blood had already adhered.  even though negative pressure was applied again, the balloon still did not enter.  therefore, they swapped the left and right, removed the ibt that had already been placed in the vertebral body on the contralateral side, and inserted  it into the one that did not enter, but it was still difficult to enter, but they forced it in and placed the product in the vertebral body.  it was said that after the operation, the sales rep confirmed a scratch on the inner cylinder of the osteo introducer, so when looked inside the outer cylinder, it seemed that there was a burr. There was no patient symptom reported. There was a delay of less than 60 minutes. There were no further complications reported regarding the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKYPHON XPANDER¿ INFLATABLE BONE TAMP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MITG - TIJUANA
blvd. insurgentes parcela #37
tijuana, bc 22570
MX 22570
Manufacturer (Section G)
MITG - TIJUANA
blvd. insurgentes parcela #37
tijuana, bc 22570
MX 22570
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key12458851
MDR Text Key272119586
Report Number2936999-2021-00890
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 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKPT1502
Device Catalogue NumberKPT1502
Device Lot Number221785907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received02/01/2022
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

-
-