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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
2014 89 89
2015 112 112
2016 857 857
2017 1404 1404
2018 1609 1609
2019 1550 1550
2020 1477 1477
2021 2006 2006
2022 2086 2086
2023 2245 2245
2024 495 495

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10117 10117
Crack 1220 1220
Naturally Worn 827 827
Fracture 777 777
Device-Device Incompatibility 632 632
Material Twisted/Bent 336 336
Material Deformation 202 202
Scratched Material 185 185
Appropriate Term/Code Not Available 166 166
Contamination /Decontamination Problem 163 163
Material Integrity Problem 120 120
Mechanical Jam 105 105
Adverse Event Without Identified Device or Use Problem 75 75
No Apparent Adverse Event 74 74
Detachment of Device or Device Component 71 71
Component Missing 57 57
Unintended Movement 54 54
Loose or Intermittent Connection 53 53
Material Fragmentation 42 42
Connection Problem 40 40
Failure to Disconnect 40 40
Insufficient Information 39 39
Entrapment of Device 34 34
Difficult to Remove 31 31
Disassembly 30 30
Illegible Information 30 30
Mechanical Problem 29 29
Device Operates Differently Than Expected 25 25
Device Contamination with Chemical or Other Material 25 25
Physical Resistance/Sticking 24 24
Material Discolored 20 20
Detachment Of Device Component 20 20
Dull, Blunt 16 16
Device Slipped 15 15
Fitting Problem 13 13
Sticking 13 13
Bent 13 13
Corroded 9 9
Use of Device Problem 9 9
Structural Problem 9 9
Device Dislodged or Dislocated 9 9
Compatibility Problem 8 8
Device Damaged by Another Device 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Defective Device 7 7
Device Reprocessing Problem 7 7
Off-Label Use 6 6
Separation Failure 6 6
Device Issue 6 6
Device Damaged Prior to Use 6 6
Improper or Incorrect Procedure or Method 5 5
Difficult to Insert 5 5
Failure To Adhere Or Bond 5 5
Component Falling 5 5
Deformation Due to Compressive Stress 5 5
Positioning Problem 5 5
Material Split, Cut or Torn 4 4
Separation Problem 4 4
Degraded 4 4
Flaked 4 4
Defective Component 4 4
Problem with Sterilization 3 3
Material Separation 3 3
Device Difficult to Setup or Prepare 3 3
Device Or Device Fragments Location Unknown 3 3
Delivered as Unsterile Product 3 3
Material Disintegration 2 2
Migration or Expulsion of Device 2 2
Failure to Cut 2 2
Material Rupture 2 2
Device Inoperable 2 2
Failure to Clean Adequately 2 2
Device Difficult to Maintain 2 2
Osseointegration Problem 2 2
Split 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Operational Issue 2 2
Material Distortion 2 2
Material Protrusion/Extrusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Expulsion 1 1
Mechanics Altered 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Missing Information 1 1
Difficult or Delayed Separation 1 1
Device Fell 1 1
Unstable 1 1
Metal Shedding Debris 1 1
Solder Joint Fracture 1 1
Residue After Decontamination 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Align 1 1
Dent in Material 1 1
Loss of Osseointegration 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6652 6652
No Consequences Or Impact To Patient 4337 4337
No Information 1181 1181
No Known Impact Or Consequence To Patient 1082 1082
Insufficient Information 384 384
No Code Available 227 227
No Patient Involvement 140 140
Not Applicable 110 110
Foreign Body In Patient 52 52
Device Embedded In Tissue or Plaque 33 33
Sedation 12 12
Pain 8 8
Injury 7 7
Unspecified Infection 7 7
Failure of Implant 4 4
Bone Fracture(s) 3 3
Reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Inadequate Osseointegration 2 2
Osteopenia/ Osteoporosis 1 1
Limited Mobility Of The Implanted Joint 1 1
Patient Problem/Medical Problem 1 1
Unspecified Musculoskeletal problem 1 1
Needle Stick/Puncture 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Thrombosis 1 1
Tissue Damage 1 1
Hematoma 1 1
Oversedation 1 1
Host-Tissue Reaction 1 1
Ossification 1 1
Eye Injury 1 1
Foreign Body Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jan-30-2012
2 Encore Medical, Lp II Mar-08-2017
3 Encore Medical, Lp II Oct-30-2015
4 Enztec Limited II Jan-24-2020
5 Exactech, Inc. II Jun-30-2023
6 Exactech, Inc. II Sep-10-2019
7 Greatbatch Medical I Nov-29-2016
8 Greatbatch Medical I Mar-06-2014
9 SpineFrontier, Inc. II Jun-05-2013
10 Stryker Howmedica Osteonics Corp. II Oct-07-2016
11 Stryker Howmedica Osteonics Corp. II Dec-27-2013
12 Stryker Howmedica Osteonics Corp. II Aug-27-2009
13 XTANT Medical II Jul-04-2020
14 Zimmer Biomet, Inc. II Feb-14-2018
15 Zimmer, Inc. II Nov-24-2014
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