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: EXACTECH, INC EQUINOXE ANATOMIC REPLICATOR PLATE
  • 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
 

EXACTECH, INC EQUINOXE ANATOMIC REPLICATOR PLATE Back to Search Results
Catalog Number 300-10-45
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 12/23/2015
Event Type  malfunction  
Manufacturer Narrative
Pending engineering evaluation.
 
Event Description
Index surgery: 2011.Revision due to glenoid and humeral loosening.
 
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of aseptic (non-infected) loosening, which damaged the bond of the implants to the bones.
 
Event Description
Index surgery: 2011.Revision due to glenoid and humeral loosening.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EQUINOXE ANATOMIC REPLICATOR PLATE
Type of Device
REPLICATOR PLATE
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key5430314
MDR Text Key38653159
Report Number1038671-2016-00138
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number300-10-45
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received01/15/2016
Was Device Evaluated by Manufacturer? Yes
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;
-
-