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: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS DISTAL FEMUR, LEFT
  • 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
 

ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS DISTAL FEMUR, LEFT Back to Search Results
Lot Number 1935219
Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
Event Date 10/10/2023
Event Type  Injury  
Manufacturer Narrative
The investigation is in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.The following mdrs were submitted for the first revision case: (b)(4).3013450937-2023-00229, 3013450937-2023-00243, 3013450937-2023-00246, 3013450937-2023-00248, 3013450937-2023-00247, 3013450937-2023-00244, 3013450937-2023-00245, 3013450937-2023-00249, 3013450937-2023-00251.Other mdrs submitted for the 2nd revision case: 3013450937-2023-00250, 3013450937-2023-00239.Other mdrs submitted for the 3rd revision case: 3013450937-2023-00253, 3013450937-2023-00252.Other mdrs submitted for the 4th revision case: 3013450937-2023-00259, 3013450937-2023-00260, 3013450937-2023-00261, 3013450937-2023-00263, 3013450937-2023-00264.
 
Event Description
This patient originally received a dfr on (b)(6) 2023 and he presented with symptoms of possible infection.The doctor decided to bring the patient back for a full washout and poly exchange.The first revision was on (b)(6) 2023 (b)(4).The second revision was on (b)(6) 2023 (b)(4).The third revision was on (b)(6) 2023.This was the fourth washout/exchange.
 
Manufacturer Narrative
Ultimately, the root cause of the patient's infection was unable to be determined.Based upon the device history records, sterilization records, and interview with the sales representative the investigation concluded that the root causes of the alleged infection is not likely due to the design, manufacture, and/or sterilization of the components.The following mdrs were submitted for the first revision case: (b)(4).3013450937-2023-00229, 3013450937-2023-00243, 3013450937-2023-00246, 3013450937-2023-00248, 3013450937-2023-00247, 3013450937-2023-00244, 3013450937-2023-00245, 3013450937-2023-00249, 3013450937-2023-00251.Other mdrs submitted for the 2nd revision case: 3013450937-2023-00250, 3013450937-2023-00239.Other mdrs submitted for the 3rd revision case: 3013450937-2023-00252, 3013450937-2023-00253.Other mdrs submitted for the 4th revision (current report) case: 3013450937-2023-00259, 3013450937-2023-00260, 3013450937-2023-00261, 3013450937-2023-00262, 3013450937-2023-00263, 3013450937-2023-00264.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELEOS LIMB SALVAGE SYSTEM
Type of Device
ELEOS DISTAL FEMUR, LEFT
Manufacturer (Section D)
ONKOS SURGICAL
77 e. halsey road
parsipanny NJ 07054
Manufacturer (Section G)
ONKOS SURGICAL
77 e. halsey road
parsipanny NJ 07054
Manufacturer Contact
vandita patel
77 e. halsey road
parsipanny, NJ 07054
MDR Report Key18091875
MDR Text Key327697787
Report Number3013450937-2023-00262
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number1935219
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
25000007E, DISTAL FEMUR, LEFT.; 25001050E, MALE FEMALE MIDSECTION, 50MM.; 25001090E, MALE FEMALE MIDSECTION, 90MM.; 25001208E, TIBIAL 8MM POLY SPACER.; DISTAL FEMUR AXIAL PIN, 25002111E.; THSMWRS01M, HINGE WITH ROTATIONAL STOP.
Patient Outcome(s) Required Intervention;
Patient Age15 YR
Patient SexMale
-
-