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

MAUDE Adverse Event Report: INSERT, 3D EX SZ 5RT 11MM

  • 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
 

INSERT, 3D EX SZ 5RT 11MM Back to Search Results
Catalog Number 392-11-705
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - due to joint laxity.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceINSERT, 3D EX SZ 5RT 11MM
MDR Report Key11823296
MDR Text Key250601979
Report Number1644408-2016-00845
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number392-11-705
Device Lot Number59603898
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
-
-