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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic tray
Regulation Description Manual surgical instrument for general use.
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
2016 1 1
2017 16 16
2018 59 59
2019 78 78
2020 38 38
2021 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 61 61
Break 35 35
Appropriate Term/Code Not Available 16 16
No Apparent Adverse Event 15 15
Fracture 10 10
Material Fragmentation 10 10
Insufficient Information 9 9
Contamination /Decontamination Problem 9 9
Device Operates Differently Than Expected 8 8
Device Contamination with Chemical or Other Material 7 7
Component Falling 5 5
Component Missing 5 5
Detachment of Device or Device Component 5 5
Material Puncture/Hole 4 4
Fire 4 4
Detachment Of Device Component 4 4
Device Fell 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Contamination 3 3
Packaging Problem 3 3
Material Split, Cut or Torn 2 2
Material Separation 2 2
Patient-Device Incompatibility 2 2
Incomplete or Missing Packaging 2 2
Delivered as Unsterile Product 2 2
Improper or Incorrect Procedure or Method 2 2
Biological Environmental Factor 2 2
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Thermal Decomposition of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Material Frayed 1 1
Leak/Splash 1 1
Migration 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Difficult to Remove 1 1
Out-Of-Box Failure 1 1
Smoking 1 1
Use of Device Problem 1 1
Microbial Contamination of Device 1 1
Fluid Leak 1 1
Overheating of Device 1 1
Separation Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 32 32
Pain 32 32
No Consequences Or Impact To Patient 22 22
Foreign Body In Patient 21 21
No Clinical Signs, Symptoms or Conditions 17 17
Inadequate Pain Relief 16 16
Insufficient Information 15 15
No Code Available 14 14
Extravasation 10 10
Necrosis 9 9
No Information 8 8
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Device Embedded In Tissue or Plaque 5 5
Pulmonary Embolism 5 5
Bone Fracture(s) 4 4
Thrombosis 3 3
Awareness during Anaesthesia 2 2
Burn(s) 2 2
Ambulation Difficulties 2 2
Cyst(s) 2 2
No Patient Involvement 2 2
Not Applicable 2 2
Patient Problem/Medical Problem 2 2
Blister 1 1
Reaction 1 1
Syncope 1 1
Edema 1 1
Seizures 1 1
Tissue Damage 1 1
Weakness 1 1
Injury 1 1
Joint Swelling 1 1
Joint Disorder 1 1
Impaired Healing 1 1
Wound Dehiscence 1 1
Numbness 1 1
Diaphoresis 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Calcium Deposits/Calcification 1 1
Fall 1 1
Inflammation 1 1
Loss of Range of Motion 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Avid Medical, Inc. II Mar-19-2020
3 Customed, Inc II Apr-14-2016
4 Medline Industries Inc II Aug-09-2021
5 Medline Industries Inc II Feb-11-2020
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