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

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL 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
 

ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 15100
Device Problems Entrapment of Device (1212); Separation Failure (2547)
Patient Problem Insufficient Information (4580)
Event Date 02/25/2021
Event Type  Injury  
Manufacturer Narrative

The device has not been returned for evaluation. The root cause is unable to be determined at this time. If any additional information is provided, a supplemental report will be submitted.

 
Event Description

Atec was notified on 06/04/2021 of an event regarding a trauma patient that underwent a posterolateral spinal surgery at l2-l5. Three months postoperative a radiograph revealed one of the screw head tabs had not detached correctly leaving a portion (approx. 1 cm) remaining in one of the screws.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINVICTUS SPINAL FIXATION SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
Manufacturer Contact
brian beireis
1950 camino vida roble
carlsbad, CA 92008
7604946739
MDR Report Key12101252
MDR Text Key259588102
Report Number2027467-2021-00045
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK181677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number15100
Device Catalogue Number15100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/01/2021 Patient Sequence Number: 1
-
-