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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 98 98

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 43 43
Material Integrity Problem 31 31
Contamination 15 15
Contamination /Decontamination Problem 13 13
Fracture 11 11
Material Fragmentation 10 10
Component Missing 9 9
Detachment of Device or Device Component 8 8
Material Puncture/Hole 6 6
Material Split, Cut or Torn 5 5
Fluid/Blood Leak 5 5
Crack 5 5
Insufficient Information 5 5
Device Contamination with Chemical or Other Material 4 4
Material Separation 4 4
Leak/Splash 3 3
Device Fell 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Packaging Problem 3 3
Incomplete or Missing Packaging 2 2
Output Problem 2 2
Device Markings/Labelling Problem 2 2
Patient-Device Incompatibility 2 2
Defective Component 2 2
Improper Chemical Reaction 2 2
Patient Device Interaction Problem 2 2
Use of Device Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Delivered as Unsterile Product 2 2
Failure to Seal 1 1
Dull, Blunt 1 1
Improper or Incorrect Procedure or Method 1 1
Flaked 1 1
Overheating of Device 1 1
Suction Problem 1 1
Migration 1 1
No Apparent Adverse Event 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Problem with Sterilization 1 1
Thermal Decomposition of Device 1 1
Material Twisted/Bent 1 1
Material Too Rigid or Stiff 1 1
Material Discolored 1 1
Unraveled Material 1 1
Degraded 1 1
Scratched Material 1 1
Microbial Contamination of Device 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 56 56
Insufficient Information 36 36
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
Ambulation Difficulties 5 5
Pulmonary Embolism 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Information 4 4
Needle Stick/Puncture 4 4
Laceration(s) 3 3
Bone Fracture(s) 3 3
Device Embedded In Tissue or Plaque 2 2
Superficial (First Degree) Burn 2 2
Fluid Discharge 2 2
Awareness during Anaesthesia 2 2
Numbness 2 2
Blister 2 2
Thrombosis 2 2
Burn(s) 2 2
Rash 2 2
Loss of Range of Motion 2 2
Inadequate Pain Relief 1 1
Swelling/ Edema 1 1
Non-union Bone Fracture 1 1
Calcium Deposits/Calcification 1 1
Reaction 1 1
Fall 1 1
No Patient Involvement 1 1
Swelling 1 1
Exposure to Body Fluids 1 1
Weakness 1 1
Foreign Body Reaction 1 1
Osteopenia/ Osteoporosis 1 1
Edema 1 1
Abrasion 1 1
Inflammation 1 1
Cyst(s) 1 1
Skin Inflammation/ Irritation 1 1
Not Applicable 1 1
Diaphoresis 1 1
Joint Disorder 1 1
Seizures 1 1
Failure of Implant 1 1
Decreased Sensitivity 1 1
Hypersensitivity/Allergic 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 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 Oct-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
16 MEDLINE INDUSTRIES, LP - Northfield II May-29-2024
17 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-10-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
21 MEDLINE INDUSTRIES, LP - Northfield II May-26-2023
22 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
26 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
27 Medline Industries Inc II Aug-09-2021
28 Medline Industries Inc II Feb-11-2020
29 ROi CPS LLC II Apr-25-2023
30 ROi CPS LLC II Nov-23-2022
31 ROi CPS LLC II Feb-28-2022
32 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
33 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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