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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device impactor
Product CodeHWA
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2018 1609 1609
2019 1550 1550
2020 1477 1477
2021 2010 2010
2022 2104 2104
2023 826 826

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6832 6832
Crack 940 940
Naturally Worn 601 601
Fracture 561 561
Device-Device Incompatibility 485 485
Material Twisted/Bent 337 337
Scratched Material 164 164
Material Deformation 163 163
Contamination /Decontamination Problem 139 139
Material Integrity Problem 97 97
Adverse Event Without Identified Device or Use Problem 71 71
Mechanical Jam 58 58
No Apparent Adverse Event 57 57
Appropriate Term/Code Not Available 55 55
Detachment of Device or Device Component 48 48
Unintended Movement 42 42
Component Missing 38 38
Loose or Intermittent Connection 37 37
Entrapment of Device 31 31
Physical Resistance/Sticking 24 24
Illegible Information 21 21
Device Contamination with Chemical or Other Material 21 21
Material Discolored 20 20
Connection Problem 19 19
Mechanical Problem 16 16
Failure to Disconnect 13 13
Dull, Blunt 12 12
Device Slipped 12 12
Use of Device Problem 10 10
Difficult to Remove 10 10
Material Fragmentation 8 8
Insufficient Information 8 8
Structural Problem 7 7
Device Damaged by Another Device 6 6
Corroded 6 6
Disassembly 5 5
Device Reprocessing Problem 5 5
Off-Label Use 5 5
Fitting Problem 5 5
Defective Device 5 5
Deformation Due to Compressive Stress 5 5
Compatibility Problem 5 5
Device Issue 4 4
Defective Component 4 4
Flaked 4 4
Separation Problem 4 4
Material Split, Cut or Torn 4 4
Positioning Problem 3 3
Degraded 3 3
Bent 3 3
Device Damaged Prior to Use 3 3
Delivered as Unsterile Product 3 3
Device Dislodged or Dislocated 3 3
Device Difficult to Maintain 2 2
Osseointegration Problem 2 2
Failure to Cut 2 2
Material Rupture 2 2
Material Disintegration 2 2
Improper or Incorrect Procedure or Method 2 2
Problem with Sterilization 2 2
Detachment Of Device Component 2 2
Difficult to Insert 2 2
Failure to Clean Adequately 2 2
Difficult or Delayed Separation 1 1
Missing Information 1 1
Device Fell 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Disconnection 1 1
Accessory Incompatible 1 1
Burst Container or Vessel 1 1
Material Separation 1 1
Product Quality Problem 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Device Or Device Fragments Location Unknown 1 1
Blocked Connection 1 1
Activation, Positioning or Separation Problem 1 1
Separation Failure 1 1
Loss of Osseointegration 1 1
Solder Joint Fracture 1 1
Residue After Decontamination 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4908 4908
No Consequences Or Impact To Patient 3980 3980
Insufficient Information 215 215
No Code Available 199 199
No Known Impact Or Consequence To Patient 187 187
Not Applicable 107 107
No Patient Involvement 89 89
No Information 49 49
Foreign Body In Patient 36 36
Device Embedded In Tissue or Plaque 7 7
Unspecified Infection 7 7
Pain 6 6
Injury 4 4
Failure of Implant 4 4
Bone Fracture(s) 3 3
Inadequate Osseointegration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Osteopenia/ Osteoporosis 1 1
Patient Problem/Medical Problem 1 1
Hematoma 1 1
Thrombosis 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Enztec Limited II Jan-24-2020
2 Exactech, Inc. II Sep-10-2019
3 XTANT Medical II Jul-04-2020
4 Zimmer Biomet, Inc. II Feb-14-2018
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