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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, surgical instrument, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeKDD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 44 44
2021 63 63
2022 12 12
2023 43 43
2024 59 59
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Lubrication 73 73
Adverse Event Without Identified Device or Use Problem 41 41
Break 15 15
Contamination /Decontamination Problem 11 11
Material Integrity Problem 9 9
Appropriate Term/Code Not Available 8 8
Device Damaged by Another Device 8 8
Output Problem 8 8
Expiration Date Error 5 5
Fluid/Blood Leak 5 5
Contamination 4 4
Delivered as Unsterile Product 4 4
No Apparent Adverse Event 4 4
Inaccurate Information 3 3
Loss of or Failure to Bond 3 3
Leak/Splash 3 3
Patient-Device Incompatibility 3 3
Device Contamination with Chemical or Other Material 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Fracture 2 2
Insufficient Information 2 2
Improper or Incorrect Procedure or Method 2 2
Packaging Problem 2 2
Material Fragmentation 2 2
Microbial Contamination of Device 2 2
Product Quality Problem 2 2
Device Markings/Labelling Problem 1 1
Sparking 1 1
Component Missing 1 1
Device-Device Incompatibility 1 1
Entrapment of Device 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Peeled/Delaminated 1 1
Electrical /Electronic Property Problem 1 1
Unsealed Device Packaging 1 1
Crack 1 1
Device Contamination with Body Fluid 1 1
Obstruction of Flow 1 1
Protective Measures Problem 1 1
Material Puncture/Hole 1 1
Device Contaminated During Manufacture or Shipping 1 1
Suction Problem 1 1
Material Disintegration 1 1
Nonstandard Device 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
Failure of Implant 28 28
Unspecified Infection 24 24
Fluid Discharge 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Pain 11 11
Wound Dehiscence 9 9
Inflammation 9 9
Purulent Discharge 7 7
Insufficient Information 7 7
Foreign Body In Patient 7 7
No Known Impact Or Consequence To Patient 7 7
Fever 5 5
Erythema 4 4
No Consequences Or Impact To Patient 4 4
Impaired Healing 4 4
No Code Available 4 4
Bacterial Infection 3 3
Post Operative Wound Infection 3 3
Necrosis 2 2
Rash 2 2
Seroma 2 2
Chills 2 2
No Patient Involvement 2 2
Device Embedded In Tissue or Plaque 2 2
Breast Discomfort/Pain 2 2
Cellulitis 1 1
Edema 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Nerve Damage 1 1
Local Reaction 1 1
Swelling 1 1
Blister 1 1
Swelling/ Edema 1 1
Sweating 1 1
Tissue Breakdown 1 1
Decreased Sensitivity 1 1
Eye Infections 1 1
Unspecified Gastrointestinal Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beaver Visitec International, Inc. II Aug-28-2024
2 Beaver Visitec International, Inc. II Mar-01-2023
3 Biomet, Inc. II Nov-15-2024
4 Bioseal Corporation II May-20-2021
5 DeRoyal Industries Inc II Nov-05-2024
6 DeRoyal Industries Inc II Jul-03-2023
7 DeRoyal Industries Inc II May-11-2020
8 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
13 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
15 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
18 MICROspecialties, Inc. II Jul-11-2024
19 Medical Action Industries, Inc. 306 II Jun-24-2021
20 Medical Action Industries, Inc. 306 II Jan-06-2020
21 Stryker Corporation II Nov-09-2023
22 Synergetics Inc I Jul-11-2024
23 Windstone Medical Packaging, Inc. I Feb-16-2024
24 Windstone Medical Packaging, Inc. II May-23-2023
25 Windstone Medical Packaging, Inc. II Jan-04-2023
26 Windstone Medical Packaging, Inc. II May-17-2022
27 Windstone Medical Packaging, Inc. II Jun-11-2021
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