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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
2015 2 2
2016 1 1
2017 15 15
2018 59 59
2019 77 77
2020 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 57 57
Break 23 23
No Apparent Adverse Event 15 15
Appropriate Term/Code Not Available 15 15
Insufficient Information 8 8
Device Operates Differently Than Expected 8 8
Material Fragmentation 8 8
Device Contamination with Chemical or Other Material 8 8
Contamination /Decontamination Problem 7 7
Component Falling 5 5
Detachment of Device or Device Component 5 5
Tip 5 5
Fire 4 4
Fracture 4 4
Detachment Of Device Component 4 4
Device Fell 3 3
Packaging Problem 3 3
Component Missing 3 3
Knife 3 3
Material Puncture/Hole 2 2
Biological Environmental Factor 2 2
Material Frayed 2 2
Delivered as Unsterile Product 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Leak/Splash 1 1
Contamination 1 1
Contamination of Device Ingredient or Reagent 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Cannula 1 1
Difficult to Remove 1 1
Material Separation 1 1
Smoking 1 1
Out-Of-Box Failure 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Needle 1 1
Cord 1 1
Improper Flow or Infusion 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 30 30
Pain 29 29
No Consequences Or Impact To Patient 22 22
Inadequate Pain Relief 16 16
No Code Available 14 14
Foreign Body In Patient 13 13
Necrosis 9 9
No Information 9 9
Extravasation 9 9
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Device Embedded In Tissue or Plaque 5 5
Bone Fracture(s) 4 4
Pulmonary Embolism 4 4
Thrombosis 3 3
Cyst(s) 2 2
Awareness during Anaesthesia 2 2
Burn(s) 2 2
Ambulation Difficulties 2 2
Not Applicable 2 2
Patient Problem/Medical Problem 2 2
No Patient Involvement 2 2
Syncope 1 1
Edema 1 1
Tissue Damage 1 1
Injury 1 1
Joint Swelling 1 1
Joint Disorder 1 1
Superficial (First Degree) Burn 1 1
Numbness 1 1
Diaphoresis 1 1
Calcium Deposits/Calcification 1 1
Inflammation 1 1
Loss of Range of Motion 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 Customed, Inc II Sep-03-2015
5 Medline Industries Inc II Feb-11-2020
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