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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device passer
Product CodeHWQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 14 14
2016 28 28
2017 39 39
2018 64 64
2019 55 55
2020 171 171
2021 160 160
2022 63 63
2023 60 60
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Break 373 373
Material Separation 54 54
Detachment of Device or Device Component 45 45
Mechanical Jam 36 36
Mechanical Problem 19 19
Failure to Advance 18 18
Fracture 16 16
Material Fragmentation 14 14
Material Integrity Problem 14 14
Detachment Of Device Component 13 13
Device Operates Differently Than Expected 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Physical Resistance/Sticking 11 11
Material Deformation 10 10
Insufficient Information 9 9
Device Damaged Prior to Use 7 7
Firing Problem 6 6
Bent 6 6
Device Dislodged or Dislocated 6 6
Material Split, Cut or Torn 5 5
Difficult to Open or Close 5 5
Device Or Device Fragments Location Unknown 5 5
Misassembled 5 5
Delivered as Unsterile Product 4 4
Device Fell 4 4
Activation, Positioning or Separation Problem 4 4
No Apparent Adverse Event 4 4
Ejection Problem 4 4
Positioning Failure 4 4
Failure to Fire 3 3
Device-Device Incompatibility 3 3
Component Falling 3 3
Metal Shedding Debris 3 3
Entrapment of Device 3 3
Nonstandard Device 3 3
Difficult to Remove 3 3
Appropriate Term/Code Not Available 2 2
Difficult to Insert 2 2
Device Packaging Compromised 2 2
Unsealed Device Packaging 2 2
Separation Problem 2 2
Failure to Cycle 2 2
Activation Problem 2 2
Separation Failure 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contamination with Chemical or Other Material 2 2
Flaked 1 1
Inaccurate Information 1 1
Installation-Related Problem 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 329 329
No Known Impact Or Consequence To Patient 225 225
No Consequences Or Impact To Patient 49 49
Foreign Body In Patient 31 31
No Information 29 29
Device Embedded In Tissue or Plaque 23 23
No Patient Involvement 14 14
Insufficient Information 7 7
Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 3 3
Hypersensitivity/Allergic reaction 2 2
Pain 2 2
Tissue Damage 2 2
Unspecified Infection 1 1
Tingling 1 1
Failure of Implant 1 1
Rupture 1 1
Chills 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Dec-23-2015
3 Biomet, Inc. II Oct-09-2014
4 Biomet, Inc. II Jun-16-2014
5 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
6 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
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