• 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 Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 06/15/2021
Event Type  Malfunction  
Manufacturer Narrative

The returned implant is currently under investigation. A follow up report with results of the investigation will be submitted upon completion.

 
Event Description

A patient underwent a spinal fusion at t10-pelvis. Postoperatively, a lateral set screw on the left connector and the medial set screw on the right connector popped off. The iliac bolt head on the left side sheared off. On (b)(6) 2021, the surgeon performed a revision surgery to remove and replace the set screws. The broken iliac bolt could not be removed; therefore, another iliac bolt was placed next to it.

 
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 (Section G)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
Manufacturer Contact
brian beireis
1950 camino vida roble
carlsbad, CA 92008
7604946739
MDR Report Key12067259
MDR Text Key264086259
Report Number2027467-2021-00046
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
Type of Report Initial
Report Date 05/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2021
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? Device Returned To Manufacturer
Date Returned to Manufacturer06/17/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated By Manufacturer? No
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: 06/25/2021 Patient Sequence Number: 1
-
-