• 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
2017 16 16
2018 59 59
2019 78 78
2020 38 38
2021 40 40
2022 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 63 63
Break 39 39
Appropriate Term/Code Not Available 18 18
No Apparent Adverse Event 15 15
Fracture 12 12
Material Fragmentation 10 10
Contamination /Decontamination Problem 9 9
Insufficient Information 9 9
Device Contamination with Chemical or Other Material 9 9
Device Operates Differently Than Expected 8 8
Detachment of Device or Device Component 7 7
Component Missing 7 7
Contamination 7 7
Fire 4 4
Component Falling 4 4
Material Puncture/Hole 4 4
Material Separation 4 4
Packaging Problem 4 4
Device Fell 4 4
Material Split, Cut or Torn 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Detachment Of Device Component 3 3
Delivered as Unsterile Product 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Biological Environmental Factor 2 2
Incomplete or Missing Packaging 2 2
Device Markings/Labelling Problem 2 2
Improper Chemical Reaction 2 2
Output Problem 2 2
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Improper Flow or Infusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Separation Problem 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Contamination of Device Ingredient or Reagent 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Smoking 1 1
Out-Of-Box Failure 1 1
Overheating of Device 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Material Frayed 1 1
Leak/Splash 1 1
Thermal Decomposition of Device 1 1
Flaked 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 35 35
No Known Impact Or Consequence To Patient 32 32
No Clinical Signs, Symptoms or Conditions 31 31
Foreign Body In Patient 28 28
No Consequences Or Impact To Patient 21 21
Insufficient Information 18 18
Inadequate Pain Relief 16 16
No Code Available 14 14
Necrosis 11 11
Extravasation 10 10
No Information 8 8
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Pulmonary Embolism 5 5
Ambulation Difficulties 5 5
Device Embedded In Tissue or Plaque 5 5
Bone Fracture(s) 4 4
Thrombosis 3 3
No Patient Involvement 2 2
Superficial (First Degree) Burn 2 2
Numbness 2 2
Loss of Range of Motion 2 2
Awareness during Anaesthesia 2 2
Burn(s) 2 2
Cyst(s) 2 2
Not Applicable 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Blister 1 1
Swelling/ Edema 1 1
Edema 1 1
Fall 1 1
Calcium Deposits/Calcification 1 1
Syncope 1 1
Seizures 1 1
Swelling 1 1
Wound Dehiscence 1 1
Inflammation 1 1
Diaphoresis 1 1
Osteopenia/ Osteoporosis 1 1
Decreased Sensitivity 1 1
Tissue Damage 1 1
Weakness 1 1
Reaction 1 1
Injury 1 1
Joint Swelling 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Impaired Healing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Sep-08-2022
3 American Contract Systems, Inc. II May-06-2022
4 Avid Medical, Inc. II Mar-19-2020
5 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
6 Medline Industries Inc II Aug-09-2021
7 Medline Industries Inc II Feb-11-2020
8 ROi CPS LLC II Nov-23-2022
9 ROi CPS LLC II Feb-28-2022
10 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
-
-