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; PEDICLE SCREW SPINAL 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; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number X022-0161
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant reported to the company that a driver broke during surgery.A dhr review was performed for the lot, and there were no manufacturing anomalies identified.The device met all required specifications prior to being made available for distribution.The device has not been received for complaint assessment.If the device is received, a follow-up report will be submitted.
 
Event or Problem Description
The complainant reported to the company that a driver broke during surgery.There were no known patient complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FORTEX PEDICLE SCREW SYSTEM
Common Device Name
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
X-SPINE SYSTEMS, INC.
664 cruiser lane
belgrade MT 59714
MDR Report Key7681893
Report Number3005031160-2018-00022
Device Sequence Number16355757
Product Code HXX
UDI-Device IdentifierM697X02201611
UDI-PublicM697X02201611
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K152132
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberX022-0161
Device Catalogue NumberN/A
Device Lot Number70014421
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2018
Initial Report FDA Received Date07/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-