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: GLOBUS MEDICAL, INC. XPAND CORPECTOMY SPACER, SMALL, 12X14
  • 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
 

GLOBUS MEDICAL, INC. XPAND CORPECTOMY SPACER, SMALL, 12X14 Back to Search Results
Model Number 116.124
Device Problem Collapse (1099)
Patient Problem Fall (1848)
Event Date 10/24/2014
Event Type  malfunction  
Event Description
It was reported to globus that an xpand spacer has collapsed after the pt fell.No revision surgery is scheduled at this time.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned for eval, and a thorough investigation could not be completed as no lot number was provided.No eval could be performed as the implant remains in the pt.No revision surgery has been scheduled.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XPAND CORPECTOMY SPACER, SMALL, 12X14
Type of Device
XPAND CORPECTOMY SPACER
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead ave.
audubon PA 19403
Manufacturer Contact
daniel paul, vp
2560 general armistead ave.
audubon, PA 19403
6109301800
MDR Report Key4308429
MDR Text Key17265194
Report Number3004142400-2014-00053
Device Sequence Number1
Product Code MQP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number116.124
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/24/2014
Initial Date FDA Received11/20/2014
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age85 YR
-
-