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: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM
  • 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
 

X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM Back to Search Results
Model Number X022-0042
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2016
Event Type  malfunction  
Event Description
Received both torque handles back for immediate testing.Original procedure was performed on this patient with an irix-a in the front on (b)(6) 2016, and a unilateral fortex construct posteriorly at the same time.A second operation was performed (b)(6) 2016 to add screws on the contralateral side to complete a bilateral construct.Surgeon is alleging that caps have disengaged from the pedicle screws from both procedures.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FORTEX PEDICLE SCREW SYSTEM
Type of Device
FORTEX PEDICLE SCREW SYSTEM
Manufacturer (Section D)
X-SPINE SYSTEMS, INC.
452 alexandersville road
miamisburg OH 45342
Manufacturer Contact
kriss anderson
452 alexandersville road
miamisburg, OH 45342
9378478400
MDR Report Key6254978
MDR Text Key64925240
Report Number3005031160-2017-00110
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberX022-0042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
IRIX-A IMPLANT
Patient Outcome(s) Other;
-
-