Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AVAFLEX CN KIT W/O NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
  • 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
 

STRYKER INSTRUMENTS-KALAMAZOO AVAFLEX CN KIT W/O NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) Back to Search Results
Model Number 1025011500
Device Problem Difficult to Remove (1528)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2020
Event Type  Injury  
Manufacturer Narrative
Not available for return.
 
Event Description
It was reported that the cement hardened too quickly around the needle which interfered with the removal of the needle.The physician made an incision to cut down the needle.There was no additional adverse consequences reported and no clinically significant medical delay.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.Device unavailable for return - discarded.
 
Event Description
It was reported that the cement hardened too quickly around the needle which interfered with the removal of the needle.The physician made an incision to cut down the needle.There was no additional adverse consequences reported and no clinically significant medical delay.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
It was reported that the cement hardened too quickly around the needle which interfered with the removal of the needle.The physician made an incision to cut down the needle.There was no additional adverse consequences reported and no clinically significant medical delay.It was further reported that the procedure was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AVAFLEX CN KIT W/O NEEDLE
Type of Device
INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9985656
MDR Text Key188490587
Report Number0001811755-2020-00936
Device Sequence Number1
Product Code OAR
UDI-Device Identifier07613327374629
UDI-Public07613327374629
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1025011500
Device Catalogue Number1025011500
Device Lot Number5991086
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-