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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
2020 38 38
2021 40 40
2022 27 27
2023 44 44
2024 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 38 38
Break 38 38
Material Integrity Problem 32 32
Adverse Event Without Identified Device or Use Problem 16 16
Contamination 15 15
Contamination /Decontamination Problem 14 14
Fracture 10 10
Component Missing 7 7
Material Fragmentation 7 7
Fluid/Blood Leak 5 5
Crack 5 5
Material Puncture/Hole 5 5
Material Split, Cut or Torn 4 4
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 4 4
Material Separation 4 4
Material Frayed 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Improper Chemical Reaction 2 2
Inadequacy of Device Shape and/or Size 2 2
Packaging Problem 2 2
Material Twisted/Bent 2 2
Use of Device Problem 2 2
Patient Device Interaction Problem 2 2
Defective Component 2 2
Device Fell 2 2
Insufficient Information 2 2
Device Markings/Labelling Problem 2 2
Output Problem 2 2
Incomplete or Missing Packaging 2 2
Leak/Splash 2 2
Scratched Material 1 1
Microbial Contamination of Device 1 1
Degraded 1 1
Moisture Damage 1 1
Unraveled Material 1 1
Material Discolored 1 1
Material Too Rigid or Stiff 1 1
Therapeutic or Diagnostic Output Failure 1 1
Thermal Decomposition of Device 1 1
Problem with Sterilization 1 1
Delivered as Unsterile Product 1 1
Patient-Device Incompatibility 1 1
Product Quality Problem 1 1
Physical Resistance/Sticking 1 1
Tear, Rip or Hole in Device Packaging 1 1
Migration 1 1
Fire 1 1
Separation Problem 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
Foreign Body In Patient 59 59
Insufficient Information 40 40
Pain 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Known Impact Or Consequence To Patient 9 9
Needle Stick/Puncture 4 4
Blister 3 3
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Ambulation Difficulties 3 3
Superficial (First Degree) Burn 2 2
No Code Available 2 2
Failure of Implant 2 2
Necrosis 2 2
Burn(s) 2 2
Rash 2 2
Fluid Discharge 2 2
Extravasation 2 2
Impaired Healing 1 1
Wound Dehiscence 1 1
Decreased Sensitivity 1 1
Hypersensitivity/Allergic reaction 1 1
Seizures 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Osteopenia/ Osteoporosis 1 1
Abrasion 1 1
Foreign Body Reaction 1 1
Weakness 1 1
Swelling 1 1
Numbness 1 1
Loss of Range of Motion 1 1
Exposure to Body Fluids 1 1
Fall 1 1
Reaction 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Device Embedded In Tissue or Plaque 1 1
Pulmonary Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems Inc II Jul-05-2024
3 American Contract Systems, Inc. II Sep-24-2024
4 American Contract Systems, Inc. II Aug-07-2024
5 American Contract Systems, Inc. II Jan-26-2024
6 American Contract Systems, Inc. III Jun-15-2023
7 American Contract Systems, Inc. II Sep-08-2022
8 American Contract Systems, Inc. II May-06-2022
9 Avid Medical, Inc. II Mar-19-2020
10 Cardinal Health 200, LLC II Jan-15-2025
11 Cardinal Health 200, LLC II Oct-10-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Nov-08-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
23 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
24 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
27 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
28 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
29 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
30 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
31 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
32 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
33 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
34 Medline Industries Inc II Aug-09-2021
35 Medline Industries Inc II Feb-11-2020
36 ROi CPS LLC II Apr-25-2023
37 ROi CPS LLC II Nov-23-2022
38 ROi CPS LLC II Feb-28-2022
39 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
40 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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