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. OPTETRAK LOGIC; LOGIC CR TIB INSERT STD, SZ 5, 9MM
  • 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. OPTETRAK LOGIC; LOGIC CR TIB INSERT STD, SZ 5, 9MM Back to Search Results
Model Number 02-012-47-5009
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Bacterial Infection (1735)
Date of Event 08/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Pending evaluation.The investigation noted that based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
 
Event or Problem Description
As reported, approximately 2 weeks after the initial left tka, for this (b)(6) y/o male patient, the stitches on the left knee were splitting so they decided to do a wash out and replace the liner.Infection was noted during the washout.The patient was last known to be in stable condition following the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTETRAK LOGIC
Common Device Name
LOGIC CR TIB INSERT STD, SZ 5, 9MM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key10561284
Report Number1038671-2020-00545
Device Sequence Number2822420
Product Code JWH
UDI-Device Identifier10885862174543
UDI-Public10885862174543
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K111400
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/19/2025
Device Model Number02-012-47-5009
Device Catalogue Number02-012-47-5009
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/31/2020
Initial Report FDA Received Date09/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age52 YR
-
-