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

MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC NEXFRAME INSTRUMENT, STEREOTAXIC

  • 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
 

QUALITY TECH SERVICES LLC NEXFRAME INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number DB-2040
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for movement disorders. It was reported that reference frame holder stripped while tightening the reference frame. It was unknown if the it was cross threaded or if there was a slight defect in the screw pattern. A new nexframe reference holder was opened and used, the issue was resolved. Additional information was received from the rep stating that the nexframe was used on the patient for the first side, but when they used it on the second side they couldn't tighten it all the way so a new nexframe was used. There were no further complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXFRAME
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
QUALITY TECH SERVICES LLC
7842 hickory flat highway
suite d
woodstock GA 30188
Manufacturer (Section G)
QUALITY TECH SERVICES LLC
7842 hickory flat highway
suite d
woodstock GA 30188
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9126066
MDR Text Key160314873
Report Number3012165443-2019-00014
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/17/2020
Device Model NumberDB-2040
Device Catalogue NumberDB-2040
Device Lot Number082516819
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-