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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device template
Product CodeHWT
Regulation Number 888.4800
Device Class 1

MDR Year MDR Reports MDR Events
2014 78 78
2015 93 93
2016 444 444
2017 651 651
2018 713 713
2019 741 741
2020 938 938
2021 2177 2177
2022 2096 2096
2023 2601 2601
2024 687 687

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5354 5354
Naturally Worn 1418 1418
Device-Device Incompatibility 1208 1208
Scratched Material 940 940
Crack 846 846
Detachment of Device or Device Component 610 610
Fracture 485 485
Material Deformation 449 449
Material Twisted/Bent 408 408
Contamination /Decontamination Problem 301 301
Illegible Information 293 293
Material Integrity Problem 194 194
Component Missing 155 155
Mechanical Jam 152 152
Appropriate Term/Code Not Available 146 146
Peeled/Delaminated 144 144
Material Discolored 144 144
Adverse Event Without Identified Device or Use Problem 111 111
Insufficient Information 89 89
No Apparent Adverse Event 65 65
Unintended Movement 64 64
Entrapment of Device 61 61
Use of Device Problem 55 55
Incorrect Measurement 50 50
Corroded 48 48
Failure to Cut 40 40
Physical Resistance/Sticking 40 40
Material Fragmentation 35 35
Disassembly 34 34
Loose or Intermittent Connection 32 32
Difficult to Remove 27 27
Device Operates Differently Than Expected 26 26
Device Dislodged or Dislocated 26 26
Structural Problem 23 23
Mechanical Problem 23 23
Bent 23 23
Device Contamination With Biological Material 22 22
Dull, Blunt 21 21
Connection Problem 18 18
Fitting Problem 17 17
Difficult to Insert 14 14
Compatibility Problem 12 12
Device Slipped 10 10
Residue After Decontamination 10 10
Improper or Incorrect Procedure or Method 10 10
Separation Failure 9 9
Off-Label Use 9 9
Difficult to Open or Close 9 9
Detachment Of Device Component 8 8
Inadequacy of Device Shape and/or Size 8 8
Loss of Osseointegration 7 7
Device Markings/Labelling Problem 7 7
Loss of or Failure to Bond 7 7
Device Operational Issue 6 6
Malposition of Device 6 6
Positioning Problem 6 6
Separation Problem 6 6
Difficult or Delayed Separation 6 6
Migration 5 5
Defective Device 5 5
Device Issue 4 4
Device Reprocessing Problem 4 4
Component Falling 4 4
Failure To Adhere Or Bond 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Distortion 3 3
Difficult to Advance 3 3
Material Split, Cut or Torn 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Degraded 3 3
Migration or Expulsion of Device 3 3
Sticking 3 3
Unstable 3 3
Device Damaged Prior to Use 3 3
Device Or Device Fragments Location Unknown 3 3
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Device Damaged by Another Device 2 2
Defective Component 2 2
Delivered as Unsterile Product 2 2
Tear, Rip or Hole in Device Packaging 2 2
Pitted 2 2
Material Disintegration 2 2
Patient Device Interaction Problem 2 2
Device Handling Problem 2 2
Torn Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Incomplete or Inadequate Connection 2 2
Inaccurate Information 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Difficult to Open or Remove Packaging Material 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Protective Measures Problem 1 1
Mechanics Altered 1 1
Noise, Audible 1 1
Display Difficult to Read 1 1
Device Expiration Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7269 7269
No Consequences Or Impact To Patient 1901 1901
No Information 623 623
No Known Impact Or Consequence To Patient 545 545
Insufficient Information 388 388
No Code Available 182 182
No Patient Involvement 168 168
Not Applicable 86 86
Pain 55 55
Foreign Body In Patient 43 43
Reaction 35 35
Unspecified Infection 29 29
Device Embedded In Tissue or Plaque 28 28
Bone Fracture(s) 24 24
Sedation 21 21
Injury 9 9
Joint Dislocation 8 8
Limb Fracture 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Loss of Range of Motion 6 6
Tissue Damage 4 4
Osteolysis 4 4
Impaired Healing 4 4
Joint Laxity 4 4
Metal Related Pathology 3 3
Unspecified Tissue Injury 3 3
Physical Asymmetry 3 3
Ambulation Difficulties 3 3
Paresis 3 3
Discomfort 3 3
Complaint, Ill-Defined 3 3
Cyst(s) 3 3
Failure of Implant 3 3
Muscle Weakness 3 3
Inflammation 2 2
Laceration(s) 2 2
Bruise/Contusion 2 2
Wound Dehiscence 2 2
Neck Pain 2 2
Joint Swelling 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Swelling 1 1
Synovitis 1 1
Paralysis 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Hematoma 1 1
Death 1 1
Fall 1 1
Fever 1 1
Foreign Body Reaction 1 1
Infiltration into Tissue 1 1
Nerve Damage 1 1
Occlusion 1 1
Blood Loss 1 1
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
Patient Problem/Medical Problem 1 1
Swelling/ Edema 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-12-2018
2 Aesculap Implant Systems LLC II Jul-31-2012
3 Biomet Microfixation, LLC II May-12-2017
4 Biomet, Inc. II Jul-14-2015
5 Biomet, Inc. II Oct-16-2014
6 DePuy Orthopaedics, Inc. II Jul-20-2022
7 DePuy Orthopaedics, Inc. II Apr-09-2014
8 DePuy Orthopaedics, Inc. II Jun-07-2013
9 Encore Medical, Lp II Jul-27-2015
10 Integra LifeSciences Corp. II Apr-20-2018
11 Materialise USA LLC II Aug-24-2022
12 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Aug-26-2013
13 Zimmer Inc. II Dec-14-2010
14 Zimmer Inc. II Jan-23-2009
15 Zimmer, Inc. II Dec-06-2013
16 Zimmer, Inc. II Nov-19-2012
17 Zimmer, Inc. II Sep-28-2012
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