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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
2018 59 59
2019 78 78
2020 38 38
2021 40 40
2022 27 27
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64 64
Break 38 38
Appropriate Term/Code Not Available 24 24
No Apparent Adverse Event 13 13
Fracture 12 12
Material Fragmentation 9 9
Component Missing 9 9
Contamination /Decontamination Problem 9 9
Contamination 8 8
Device Operates Differently Than Expected 8 8
Device Contamination with Chemical or Other Material 8 8
Insufficient Information 7 7
Detachment of Device or Device Component 7 7
Material Separation 4 4
Material Puncture/Hole 4 4
Device Fell 4 4
Packaging Problem 3 3
Material Split, Cut or Torn 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Detachment Of Device Component 3 3
Component Falling 3 3
Fire 2 2
Delivered as Unsterile Product 2 2
Inadequacy of Device Shape and/or Size 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Incomplete or Missing Packaging 2 2
Device Markings/Labelling Problem 2 2
Patient-Device Incompatibility 2 2
Output Problem 2 2
Improper Chemical Reaction 2 2
Improper Flow or Infusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Physical Resistance/Sticking 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Therapeutic or Diagnostic Output Failure 1 1
Separation Problem 1 1
Biological Environmental Factor 1 1
Out-Of-Box Failure 1 1
Contamination of Device Ingredient or Reagent 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Microbial Contamination of Device 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
Flaked 1 1
Fluid/Blood Leak 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
Pain 33 33
Foreign Body In Patient 31 31
No Known Impact Or Consequence To Patient 28 28
Insufficient Information 18 18
No Consequences Or Impact To Patient 17 17
Inadequate Pain Relief 15 15
No Code Available 14 14
Necrosis 11 11
Extravasation 10 10
Host-Tissue Reaction 7 7
No Information 6 6
Pulmonary Embolism 5 5
Unspecified Infection 5 5
Ambulation Difficulties 5 5
Bone Fracture(s) 4 4
Needle Stick/Puncture 3 3
Thrombosis 3 3
Device Embedded In Tissue or Plaque 3 3
Not Applicable 2 2
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 2 2
Fluid Discharge 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Numbness 2 2
No Patient Involvement 2 2
Loss of Range of Motion 2 2
Rash 2 2
Awareness during Anaesthesia 2 2
Burn(s) 2 2
Cyst(s) 2 2
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
Osteopenia/ Osteoporosis 1 1
Decreased Sensitivity 1 1
Diaphoresis 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
Blister 1 1
Swelling/ Edema 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 - Northfield II May-26-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
10 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
11 Medline Industries Inc II Aug-09-2021
12 Medline Industries Inc II Feb-11-2020
13 ROi CPS LLC II Apr-25-2023
14 ROi CPS LLC II Nov-23-2022
15 ROi CPS LLC II Feb-28-2022
16 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
17 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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