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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 62 62
Break 38 38
Appropriate Term/Code Not Available 16 16
No Apparent Adverse Event 15 15
Fracture 11 11
Material Fragmentation 10 10
Contamination /Decontamination Problem 9 9
Insufficient Information 9 9
Device Operates Differently Than Expected 8 8
Device Contamination with Chemical or Other Material 8 8
Detachment of Device or Device Component 7 7
Component Missing 6 6
Contamination 5 5
Fire 4 4
Material Puncture/Hole 4 4
Material Separation 4 4
Component Falling 4 4
Packaging Problem 4 4
Device Fell 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Split, Cut or Torn 3 3
Detachment Of Device Component 3 3
Delivered as Unsterile Product 2 2
Improper or Incorrect Procedure or Method 2 2
Incomplete or Missing Packaging 2 2
Patient-Device Incompatibility 2 2
Biological Environmental Factor 2 2
Device Markings/Labelling Problem 2 2
Output Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Separation Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Improper Flow or Infusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Out-Of-Box Failure 1 1
Overheating of Device 1 1
Fluid Leak 1 1
Smoking 1 1
Use of Device Problem 1 1
Difficult to Remove 1 1
Thermal Decomposition of Device 1 1
Material Frayed 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 34 34
No Known Impact Or Consequence To Patient 32 32
No Clinical Signs, Symptoms or Conditions 24 24
Foreign Body In Patient 24 24
No Consequences Or Impact To Patient 21 21
Insufficient Information 17 17
Inadequate Pain Relief 16 16
No Code Available 14 14
Necrosis 10 10
Extravasation 10 10
No Information 8 8
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Pulmonary Embolism 5 5
Device Embedded In Tissue or Plaque 5 5
Bone Fracture(s) 4 4
Ambulation Difficulties 4 4
Thrombosis 3 3
No Patient Involvement 2 2
Patient Problem/Medical Problem 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
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
Superficial (First Degree) Burn 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 May-06-2022
3 Avid Medical, Inc. II Mar-19-2020
4 Medline Industries Inc II Aug-09-2021
5 Medline Industries Inc II Feb-11-2020
6 ROi CPS LLC II Feb-28-2022
7 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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