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

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® SOLERA® SPINAL 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
 

WARSAW ORTHOPEDICS CD HORIZON® SOLERA® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 641003045
Device Problems Unstable (1667); Device Damaged by Another Device (2915)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/28/2021
Event Type  Injury  
Manufacturer Narrative
Procedure has been changed from mis (minimally invasive surgery) to open procedure. Evaluation of the returned device was not completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from distributor via manufacturer representative regarding an event happened during intra-op for a patient undergoing minimally invasive procedure for l5 pars fracture. Levels implanted were mentioned as l5. It was reported that, when trying to make the construct strong and stable, it added a lot of time to the case and caused extra blood lose and time under anesthetics. Case went from being mis to open procedure. The set screws after trying twice were just not engaging and left the construct unstable and the rod compromised. The set screw did not fully engage with rod causing construct to be weak and rod to move. Set screw had to be revised after break off and a new solera set screw implanted. Construct was still weak and loose and the integrity of the rod had now been compromised twice. Rod and set screws were then explanted. Set screw did not fully engage with rod causing construct instability. Rod endured x4 break offs and the construct was still loose and unable to be left as is. The strength and integrity of the construct had now been compromised and the rod had endured micro fractures from the break off so rod and set screws were explanted. Overall procedure increased 2 hours ¿ 5 hours. No further complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCD HORIZON® SOLERA® SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key12647083
MDR Text Key276870031
Report Number1030489-2021-01285
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K132639
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/09/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number641003045
Device Catalogue Number641003045
Device Lot Number0705568W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2019
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: 10/18/2021 Patient Sequence Number: 1
-
-