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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device orthopedic tray
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJH
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 16 16
2018 59 59
2019 78 78
2020 38 38
2021 40 40
2022 27 27
2023 44 44
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 66 66
Break 54 54
Appropriate Term/Code Not Available 39 39
Material Integrity Problem 23 23
Contamination 15 15
No Apparent Adverse Event 15 15
Fracture 13 13
Contamination /Decontamination Problem 12 12
Material Fragmentation 12 12
Device Contamination with Chemical or Other Material 11 11
Insufficient Information 10 10
Component Missing 9 9
Device Operates Differently Than Expected 8 8
Detachment of Device or Device Component 8 8
Material Puncture/Hole 6 6
Material Split, Cut or Torn 5 5
Packaging Problem 5 5
Component Falling 5 5
Detachment Of Device Component 4 4
Material Separation 4 4
Fire 4 4
Device Fell 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Crack 3 3
Output Problem 2 2
Improper Chemical Reaction 2 2
Device Markings/Labelling Problem 2 2
Incomplete or Missing Packaging 2 2
Biological Environmental Factor 2 2
Inadequacy of Device Shape and/or Size 2 2
Leak/Splash 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Use of Device Problem 2 2
Delivered as Unsterile Product 2 2
Material Frayed 2 2
Smoking 1 1
Suction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Problem with Sterilization 1 1
Difficult to Remove 1 1
Material Twisted/Bent 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Migration 1 1
Material Discolored 1 1
Contamination of Device Ingredient or Reagent 1 1
Physical Resistance/Sticking 1 1
Device Contaminated During Manufacture or Shipping 1 1
Patient Device Interaction Problem 1 1
Device Issue 1 1
Out-Of-Box Failure 1 1
Thermal Decomposition of Device 1 1
Moisture Damage 1 1
Dull, Blunt 1 1
Flaked 1 1
Scratched Material 1 1
Improper Flow or Infusion 1 1
Microbial Contamination of Device 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1
Separation Problem 1 1
Inaccurate Delivery 1 1
Overheating of Device 1 1
Split 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
Foreign Body In Patient 57 57
Pain 35 35
Insufficient Information 34 34
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 22 22
Inadequate Pain Relief 16 16
No Code Available 14 14
Necrosis 11 11
No Information 10 10
Extravasation 10 10
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Device Embedded In Tissue or Plaque 5 5
Ambulation Difficulties 5 5
Pulmonary Embolism 5 5
Bone Fracture(s) 4 4
Needle Stick/Puncture 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Burn(s) 3 3
Thrombosis 3 3
Cyst(s) 2 2
Loss of Range of Motion 2 2
Not Applicable 2 2
Superficial (First Degree) Burn 2 2
No Patient Involvement 2 2
Laceration(s) 2 2
Awareness during Anaesthesia 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 2 2
Blister 2 2
Numbness 2 2
Rash 2 2
Wound Dehiscence 1 1
Decreased Sensitivity 1 1
Osteopenia/ Osteoporosis 1 1
Calcium Deposits/Calcification 1 1
Injury 1 1
Joint Disorder 1 1
Joint Swelling 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Edema 1 1
Fall 1 1
Diaphoresis 1 1
Impaired Healing 1 1
Syncope 1 1
Weakness 1 1
Reaction 1 1
Seizures 1 1
Exposure to Body Fluids 1 1
Failure of Implant 1 1
Tissue Damage 1 1
Foreign Body Reaction 1 1
Inflammation 1 1
Abrasion 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. III Jun-15-2023
4 American Contract Systems, Inc. II Sep-08-2022
5 American Contract Systems, Inc. II May-06-2022
6 Avid Medical, Inc. II Mar-19-2020
7 Cardinal Health 200, LLC II Oct-10-2023
8 Customed, Inc II Apr-14-2016
9 Customed, Inc II Sep-03-2015
10 Customed, Inc I Dec-16-2014
11 Customed, Inc I Aug-29-2014
12 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
16 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
21 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
22 Medline Industries Inc II Aug-09-2021
23 Medline Industries Inc II Feb-11-2020
24 ROi CPS LLC II Apr-25-2023
25 ROi CPS LLC II Nov-23-2022
26 ROi CPS LLC II Feb-28-2022
27 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
28 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
-
-