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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical, instrument
Regulation Description Manual surgical instrument for general use.
Product CodeFSM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 148 148
2021 153 153
2022 200 200
2023 170 170
2024 288 288
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 467 467
Break 172 172
Contamination /Decontamination Problem 158 158
Crack 88 88
Naturally Worn 79 79
Flaked 41 41
Material Discolored 40 40
Fracture 39 39
Material Twisted/Bent 29 29
Material Integrity Problem 21 21
No Apparent Adverse Event 18 18
Corroded 18 18
Component Missing 13 13
Unsealed Device Packaging 12 12
Scratched Material 12 12
Material Deformation 12 12
Incorrect Measurement 11 11
Material Fragmentation 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Illegible Information 9 9
Detachment of Device or Device Component 7 7
Appropriate Term/Code Not Available 6 6
Mechanical Problem 5 5
Device-Device Incompatibility 4 4
Degraded 4 4
Use of Device Problem 4 4
Structural Problem 4 4
Product Quality Problem 3 3
Dull, Blunt 2 2
Sparking 2 2
Microbial Contamination of Device 2 2
Device Reprocessing Problem 2 2
Premature Separation 2 2
Defective Device 2 2
Connection Problem 2 2
Overheating of Device 2 2
Residue After Decontamination 2 2
Entrapment of Device 2 2
Device Contaminated During Manufacture or Shipping 1 1
Particulates 1 1
Mechanical Jam 1 1
Delivered as Unsterile Product 1 1
Contamination 1 1
Melted 1 1
Failure to Deliver Energy 1 1
Electrical /Electronic Property Problem 1 1
Defective Component 1 1
Inadequate Instructions for Healthcare Professional 1 1
Inaccurate Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 770 770
No Consequences Or Impact To Patient 101 101
Insufficient Information 86 86
No Patient Involvement 14 14
No Known Impact Or Consequence To Patient 11 11
No Code Available 11 11
Not Applicable 5 5
Failure of Implant 3 3
Foreign Body In Patient 3 3
Laceration(s) 3 3
Metal Related Pathology 2 2
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Burn(s) 1 1
Death 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Injury 1 1
Joint Dislocation 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Loss of Range of Motion 1 1
Joint Laxity 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Apr-25-2023
2 Howmedica Osteonics Corp. II Jan-06-2022
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 Medical Action Industries, Inc. 306 II Sep-12-2024
6 Stradis Healthcare II Jan-11-2023
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