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: ZYGA TECHNOLOGY, INC. SIMMETRY 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
 

ZYGA TECHNOLOGY, INC. SIMMETRY SYSTEM Back to Search Results
Model Number 90054-60
Device Problem Fitting Problem (2183)
Patient Problems Failure of Implant (1924); Weakness (2145)
Event Date 10/18/2016
Event Type  Injury  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
The patient had sij fusion surgery (b)(6) 2016 with 100% relief of pain symptoms and no other complaints at a two-week follow-up appointment.The patient later reported some weakness in the left leg.A ct confirmed that one of the implanted devices was encroaching the neural foramen.The surgeon removed the device and replaced it with a different size implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIMMETRY SYSTEM
Type of Device
SIMMETRY
Manufacturer (Section D)
ZYGA TECHNOLOGY, INC.
5600 rowland road
suite 200
minnetonka MN 55343
Manufacturer (Section G)
ZYGA TECHNOLOGY, INC.
5600 rowland road
suite 200
minnetonka MN 55343
Manufacturer Contact
lisa ingham
5600 rowland road
suite 200
minnetonka, MN 55343
9526989958
MDR Report Key6090835
MDR Text Key59551821
Report Number3008875054-2016-00020
Device Sequence Number1
Product Code OUR
Combination Product (y/n)N
PMA/PMN Number
K141549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/10/2021
Device Model Number90054-60
Device Catalogue Number10-P12560-01
Device Lot Number150673
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-