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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
No Apparent Adverse Event 15 15
Contamination /Decontamination Problem 15 15
Contamination 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
Detachment of Device or Device Component 8 8
Device Operates Differently Than Expected 8 8
Material Puncture/Hole 6 6
Material Split, Cut or Torn 5 5
Crack 5 5
Packaging Problem 5 5
Fluid/Blood Leak 5 5
Component Falling 5 5
Material Separation 4 4
Fire 4 4
Detachment Of Device Component 4 4
Device Fell 4 4
Leak/Splash 3 3
Material Frayed 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Inadequacy of Device Shape and/or Size 2 2
Delivered as Unsterile Product 2 2
Biological Environmental Factor 2 2
Use of Device Problem 2 2
Improper Chemical Reaction 2 2
Improper or Incorrect Procedure or Method 2 2
Patient Device Interaction Problem 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 2 2
Incomplete or Missing Packaging 2 2
Output Problem 2 2
Suction Problem 1 1
Inaccurate Delivery 1 1
Overheating of Device 1 1
Flaked 1 1
Device Issue 1 1
Contamination of Device Ingredient or Reagent 1 1
Product Quality Problem 1 1
Migration 1 1
Failure to Seal 1 1
Temperature Problem 1 1
Dull, Blunt 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
No Information 10 10
Extravasation 10 10
Host-Tissue Reaction 7 7
Unspecified Infection 6 6
Ambulation Difficulties 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pulmonary Embolism 5 5
Device Embedded In Tissue or Plaque 5 5
Bone Fracture(s) 4 4
Needle Stick/Puncture 4 4
Laceration(s) 3 3
Burn(s) 3 3
Thrombosis 3 3
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 2 2
Not Applicable 2 2
Cyst(s) 2 2
Fluid Discharge 2 2
Blister 2 2
Awareness during Anaesthesia 2 2
Rash 2 2
No Patient Involvement 2 2
Loss of Range of Motion 2 2
Numbness 2 2
Tissue Damage 1 1
Swelling/ Edema 1 1
Non-union Bone Fracture 1 1
Calcium Deposits/Calcification 1 1
Reaction 1 1
Fall 1 1
Exposure to Body Fluids 1 1
Swelling 1 1
Joint Swelling 1 1
Weakness 1 1
Injury 1 1
Foreign Body Reaction 1 1
Abrasion 1 1
Osteopenia/ Osteoporosis 1 1
Edema 1 1
Inflammation 1 1
Skin Inflammation/ Irritation 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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