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

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM LT FLANGED C

  • 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
 

ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM LT FLANGED C Back to Search Results
Catalog Number 114904
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 02/18/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as fracture. The reported previous surgery and the surgery detailed in this event occurred 4. 3 years apart. No dticket/invoice was provided to verify the previous surgery. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device were disposed of at hospital and not made available to djo surgical for examination. The revised items were not returned for examination and lot numbers were not provided. To adequately investigate this event, the lot numbers are necessary. If this information is submitted at a future date, this investigation will be re-evaluated. There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event. The surgeon performed this revision to remedy the patient's condition. This complaint will be closed pending receipt of additional information.
 
Event Description
Revision surgery - due to fracture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 4X100MM LT FLANGED C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445,
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445,
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445, 
MDR Report Key9843121
MDR Text Key183879553
Report Number1644408-2020-00203
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114904
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
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 Treatment Data
Date Received: 03/17/2020 Patient Sequence Number: 1
-
-