Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3 3

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 16 16
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
Fluid/Blood Leak 5 5
Expiration Date Error 5 5
Improper or Incorrect Procedure or Method 4 4
No Apparent Adverse Event 4 4
Delivered as Unsterile Product 4 4
Contamination 4 4
Patient-Device Incompatibility 3 3
Material Fragmentation 3 3
Device Contamination with Chemical or Other Material 3 3
Inaccurate Information 3 3
Loss of or Failure to Bond 3 3
Leak/Splash 3 3
Insufficient Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Microbial Contamination of Device 2 2
Packaging Problem 2 2
Product Quality Problem 2 2
Fracture 2 2
Material Puncture/Hole 1 1
Unsealed Device Packaging 1 1
Material Disintegration 1 1
Device Markings/Labelling Problem 1 1
Peeled/Delaminated 1 1
Crack 1 1
Use of Device Problem 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Device Contamination with Body Fluid 1 1
Off-Label Use 1 1
Entrapment of Device 1 1
Material Deformation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contaminated During Manufacture or Shipping 1 1
Protective Measures Problem 1 1
Device-Device Incompatibility 1 1
Nonstandard Device 1 1
Suction Problem 1 1
Electrical /Electronic Property Problem 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 99 99
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
Foreign Body In Patient 8 8
Purulent Discharge 7 7
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 7 7
Fever 5 5
Impaired Healing 4 4
No Code Available 4 4
Erythema 4 4
No Consequences Or Impact To Patient 4 4
Post Operative Wound Infection 3 3
Bacterial 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
Sweating 1 1
Decreased Sensitivity 1 1
Unspecified Gastrointestinal Problem 1 1
Muscle Weakness 1 1
Edema 1 1
Itching Sensation 1 1
Local Reaction 1 1
Blister 1 1
Cellulitis 1 1
Nerve Damage 1 1
Swelling 1 1
Eye Infections 1 1
Swelling/ Edema 1 1
Tissue Breakdown 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
-
-