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

MAUDE Adverse Event Report: SPINAL ELEMENTS, INC SAVANNAH 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
 

SPINAL ELEMENTS, INC SAVANNAH THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Fracture (1260); Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
The original surgery was 7 years ago. Allegedly there is pseudarthrosis, but no further surgical information was given. Dhr review cannot be completed as no device information has been received. No evaluation of the device can be performed, as the device was not returned. Unknown factors include: exact implant duration, patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort. Root cause or specific failure mode cannot be determined. Labeling review notes: "warnings: devices are not intended to be the sole means of spinal support. Use of these products without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will occur.
 
Event Description
Reportedly a patient received intervertebral body fusion procedure with posterior fixtation (l2-l3) in 2013. On (b)(6) 2020 it was reported that the left l3 pedicle bone screw fractured as a result of non-union/pseudarthrosis. Revision surgery is planned. No further event details were given. Patient status is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSAVANNAH
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
SPINAL ELEMENTS, INC
3115 melrose drive, suite 200
carlsbad CA 92010
Manufacturer Contact
peter perhach
3115 melrose drive, suite 200
carlsbad, CA 92010
7606071830
MDR Report Key11037877
MDR Text Key222408090
Report Number3004893332-2020-00015
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received12/01/2020
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: 12/18/2020 Patient Sequence Number: 1
-
-