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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device tray, surgical, instrument
Product CodeFSM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 168 168
2020 148 148
2021 153 153
2022 200 200
2023 170 170
2024 194 194

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 430 430
Break 233 233
Contamination /Decontamination Problem 158 158
Crack 91 91
Naturally Worn 90 90
Material Twisted/Bent 53 53
Flaked 41 41
Fracture 38 38
Material Discolored 31 31
Incorrect Measurement 20 20
Corroded 19 19
Adverse Event Without Identified Device or Use Problem 19 19
No Apparent Adverse Event 18 18
Material Integrity Problem 17 17
Scratched Material 14 14
Component Missing 14 14
Material Fragmentation 11 11
Detachment of Device or Device Component 8 8
Patient-Device Incompatibility 7 7
Material Deformation 7 7
Unsealed Device Packaging 7 7
Illegible Information 7 7
Mechanical Problem 6 6
Device-Device Incompatibility 6 6
Dull, Blunt 5 5
Structural Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Product Quality Problem 4 4
Degraded 4 4
Entrapment of Device 3 3
Loose or Intermittent Connection 3 3
Use of Device Problem 3 3
Connection Problem 3 3
Device Displays Incorrect Message 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 2 2
Premature Separation 2 2
Sparking 2 2
Residue After Decontamination 2 2
Overheating of Device 2 2
Defective Device 2 2
Packaging Problem 2 2
Defective Component 2 2
Microbial Contamination of Device 2 2
Difficult to Remove 2 2
Loss of or Failure to Bond 2 2
Device Reprocessing Problem 2 2
Contamination 2 2
Positioning Failure 1 1
Failure to Discharge 1 1
Inadequate Instructions for Healthcare Professional 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Fluid/Blood Leak 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Device Damaged Prior to Use 1 1
Melted 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Particulates 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Failure to Align 1 1
Separation Failure 1 1
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Environmental Compatibility Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 663 663
No Consequences Or Impact To Patient 232 232
Insufficient Information 68 68
No Known Impact Or Consequence To Patient 20 20
No Code Available 19 19
No Patient Involvement 17 17
Not Applicable 10 10
Pain 7 7
Failure of Implant 6 6
Foreign Body In Patient 4 4
Bone Fracture(s) 3 3
Laceration(s) 3 3
Injury 2 2
Unspecified Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Metal Related Pathology 2 2
Joint Laxity 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
Patient Problem/Medical Problem 1 1
Inadequate Osseointegration 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Burn(s) 1 1
Cataract 1 1
Death 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Nerve Damage 1 1
Loss of Range of Motion 1 1
Retinal Injury 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 I Feb-25-2024
4 Stradis Healthcare II Jan-11-2023
5 Zimmer Biomet, Inc. II Jul-12-2019
6 Zimmer Biomet, Inc. II Jan-14-2019
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