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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
2015 2 2
2016 1 1
2017 16 16
2018 59 59
2019 78 78
2020 38 38
2021 40 40
2022 27 27
2023 44 44
2024 98 98

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 66 66
Break 54 54
Appropriate Term/Code Not Available 48 48
Material Integrity Problem 31 31
Contamination /Decontamination Problem 15 15
Contamination 15 15
No Apparent Adverse Event 15 15
Fracture 14 14
Material Fragmentation 13 13
Device Contamination with Chemical or Other Material 11 11
Insufficient Information 10 10
Component Missing 9 9
Device Operates Differently Than Expected 8 8
Detachment of Device or Device Component 8 8
Material Puncture/Hole 6 6
Component Falling 5 5
Fluid/Blood Leak 5 5
Packaging Problem 5 5
Material Split, Cut or Torn 5 5
Crack 5 5
Detachment Of Device Component 4 4
Fire 4 4
Material Separation 4 4
Device Fell 4 4
Leak/Splash 3 3
Material Frayed 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Incomplete or Missing Packaging 2 2
Output Problem 2 2
Improper Chemical Reaction 2 2
Inadequacy of Device Shape and/or Size 2 2
Biological Environmental Factor 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Delivered as Unsterile Product 2 2
Use of Device Problem 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Smoking 1 1
Unraveled Material 1 1
Degraded 1 1
Out-Of-Box Failure 1 1
Split 1 1
Thermal Decomposition of Device 1 1
Problem with Sterilization 1 1
Device Contaminated During Manufacture or Shipping 1 1
Separation Problem 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 104
Foreign Body In Patient 63 63
Insufficient Information 37 37
Pain 35 35
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 22 22
Inadequate Pain Relief 16 16
No Code Available 14 14
Necrosis 11 11
Extravasation 10 10
No Information 10 10
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Device Embedded In Tissue or Plaque 5 5
Ambulation Difficulties 5 5
Pulmonary Embolism 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Needle Stick/Puncture 4 4
Bone Fracture(s) 4 4
Laceration(s) 3 3
Thrombosis 3 3
Burn(s) 3 3
Blister 2 2
Cyst(s) 2 2
Rash 2 2
Not Applicable 2 2
Loss of Range of Motion 2 2
Numbness 2 2
No Patient Involvement 2 2
Awareness during Anaesthesia 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 2 2
Abrasion 1 1
Edema 1 1
Osteopenia/ Osteoporosis 1 1
Foreign Body Reaction 1 1
Inflammation 1 1
Weakness 1 1
Injury 1 1
Skin Inflammation/ Irritation 1 1
Exposure to Body Fluids 1 1
Swelling 1 1
Diaphoresis 1 1
Joint Swelling 1 1
Joint Disorder 1 1
Fall 1 1
Seizures 1 1
Failure of Implant 1 1
Reaction 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 Aug-07-2024
4 American Contract Systems, Inc. II Jan-26-2024
5 American Contract Systems, Inc. III Jun-15-2023
6 American Contract Systems, Inc. II Sep-08-2022
7 American Contract Systems, Inc. II May-06-2022
8 Avid Medical, Inc. II Mar-19-2020
9 Cardinal Health 200, LLC II Oct-10-2023
10 Customed, Inc II Apr-14-2016
11 Customed, Inc II Sep-03-2015
12 Customed, Inc I Dec-16-2014
13 Customed, Inc I Aug-29-2014
14 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
19 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
20 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
24 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
27 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
28 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
29 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
30 Medline Industries Inc II Aug-09-2021
31 Medline Industries Inc II Feb-11-2020
32 ROi CPS LLC II Apr-25-2023
33 ROi CPS LLC II Nov-23-2022
34 ROi CPS LLC II Feb-28-2022
35 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
36 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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