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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 1307 1307

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10653 10653
Crack 1298 1298
Naturally Worn 945 945
Fracture 843 843
Device-Device Incompatibility 703 703
Material Twisted/Bent 337 337
Material Deformation 215 215
Scratched Material 204 204
Contamination /Decontamination Problem 191 191
Appropriate Term/Code Not Available 166 166
Material Integrity Problem 126 126
Mechanical Jam 108 108
No Apparent Adverse Event 106 106
Detachment of Device or Device Component 78 78
Adverse Event Without Identified Device or Use Problem 75 75
Unintended Movement 62 62
Component Missing 57 57
Loose or Intermittent Connection 53 53
Material Fragmentation 42 42
Failure to Disconnect 40 40
Connection Problem 40 40
Insufficient Information 39 39
Entrapment of Device 38 38
Illegible Information 33 33
Difficult to Remove 31 31
Disassembly 30 30
Mechanical Problem 29 29
Device Contamination with Chemical or Other Material 25 25
Device Operates Differently Than Expected 25 25
Physical Resistance/Sticking 24 24
Material Discolored 21 21
Detachment Of Device Component 20 20
Dull, Blunt 16 16
Device Slipped 15 15
Sticking 13 13
Bent 13 13
Fitting Problem 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Corroded 11 11
Device Dislodged or Dislocated 9 9
Use of Device Problem 9 9
Structural Problem 9 9
Compatibility Problem 8 8
Device Damaged by Another Device 8 8
Defective Device 7 7
Device Reprocessing Problem 7 7
Separation Failure 6 6
Device Damaged Prior to Use 6 6
Off-Label Use 6 6
Device Issue 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7243 7243
No Consequences Or Impact To Patient 4337 4337
No Information 1181 1181
No Known Impact Or Consequence To Patient 1082 1082
Insufficient Information 641 641
No Code Available 227 227
No Patient Involvement 140 140
Not Applicable 110 110
Foreign Body In Patient 59 59
Device Embedded In Tissue or Plaque 33 33
Sedation 12 12
Pain 8 8
Unspecified Infection 7 7
Injury 7 7
Failure of Implant 4 4
Bone Fracture(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Inadequate Osseointegration 2 2
Reaction 2 2
Patient Problem/Medical Problem 1 1
Limited Mobility Of The Implanted Joint 1 1
Joint Disorder 1 1
Unspecified Musculoskeletal problem 1 1
Hematoma 1 1
Osteopenia/ Osteoporosis 1 1
Ossification 1 1
Foreign Body Reaction 1 1
Oversedation 1 1
Needle Stick/Puncture 1 1
Thrombosis 1 1
Eye Injury 1 1
Host-Tissue Reaction 1 1
Non-union Bone Fracture 1 1
Tissue Damage 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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