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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYGA TECHNOLOGY, INC. SIMMETRY SACROILIAC JOINT FUSION SYSTEM
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ZYGA TECHNOLOGY, INC. SIMMETRY SACROILIAC JOINT FUSION SYSTEM Back to Search Results
Model Number ZYG-10076
Device Problem Use of Device Problem (1670)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001); No Code Available (3191)
Event Date 11/14/2017
Event Type  Injury  
Event Description
The surgeon was conducting an sij fusion procedure per standard technique.After drilling across the sacrum he noticed increased bleeding which was addressed intraoperatively.Postoperatively the patient developed foot drop.Imaging revealed a hematoma at the surgical site from presumably nicking the gluteal artery or a branch of the artery.The patient was brought back into the or to evacuate the hematoma.The following day the patient was doing well and foot drop resolved.
 
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Brand Name
SIMMETRY SACROILIAC JOINT FUSION 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 Key7087699
MDR Text Key93879456
Report Number3008875054-2017-00019
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
PMA/PMN Number
K151818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberZYG-10076
Device Catalogue NumberZYG-10076
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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