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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
2019 78 78
2020 38 38
2021 40 40
2022 27 27
2023 44 44
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 56 56
Break 44 44
Appropriate Term/Code Not Available 34 34
Material Integrity Problem 23 23
Contamination 15 15
Fracture 10 10
Contamination /Decontamination Problem 10 10
Component Missing 9 9
Material Fragmentation 9 9
Detachment of Device or Device Component 8 8
Material Puncture/Hole 6 6
Material Split, Cut or Torn 5 5
Insufficient Information 5 5
Material Separation 4 4
Device Contamination with Chemical or Other Material 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Crack 3 3
Device Fell 3 3
Packaging Problem 3 3
Output Problem 2 2
Leak/Splash 2 2
Inadequacy of Device Shape and/or Size 2 2
Delivered as Unsterile Product 2 2
Patient-Device Incompatibility 2 2
Improper Chemical Reaction 2 2
Device Markings/Labelling Problem 2 2
Incomplete or Missing Packaging 2 2
Use of Device Problem 2 2
Defective Component 2 2
Microbial Contamination of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Twisted/Bent 1 1
Overheating of Device 1 1
Thermal Decomposition of Device 1 1
Problem with Sterilization 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Moisture Damage 1 1
Material Discolored 1 1
Fire 1 1
Flaked 1 1
Fluid/Blood Leak 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Separation Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
Foreign Body In Patient 50 50
Insufficient Information 33 33
Pain 30 30
No Known Impact Or Consequence To Patient 20 20
No Code Available 14 14
Necrosis 9 9
No Consequences Or Impact To Patient 8 8
Extravasation 6 6
Pulmonary Embolism 5 5
Ambulation Difficulties 5 5
Needle Stick/Puncture 4 4
No Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Bone Fracture(s) 3 3
Laceration(s) 2 2
Awareness during Anaesthesia 2 2
Burn(s) 2 2
Thrombosis 2 2
Numbness 2 2
Loss of Range of Motion 2 2
Rash 2 2
Blister 2 2
Superficial (First Degree) Burn 2 2
Fluid Discharge 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 1 1
Patient Problem/Medical Problem 1 1
Swelling/ Edema 1 1
Seizures 1 1
Swelling 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Diaphoresis 1 1
Weakness 1 1
No Patient Involvement 1 1
Osteopenia/ Osteoporosis 1 1
Decreased Sensitivity 1 1
Calcium Deposits/Calcification 1 1
Cyst(s) 1 1
Edema 1 1
Exposure to Body Fluids 1 1
Syncope 1 1
Abrasion 1 1
Wound Dehiscence 1 1
Fall 1 1
Foreign Body Reaction 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. III Jun-15-2023
4 American Contract Systems, Inc. II Sep-08-2022
5 American Contract Systems, Inc. II May-06-2022
6 Avid Medical, Inc. II Mar-19-2020
7 Cardinal Health 200, LLC II Oct-10-2023
8 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
17 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
18 Medline Industries Inc II Aug-09-2021
19 Medline Industries Inc II Feb-11-2020
20 ROi CPS LLC II Apr-25-2023
21 ROi CPS LLC II Nov-23-2022
22 ROi CPS LLC II Feb-28-2022
23 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
24 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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