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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 225 225
2018 433 433
2019 460 460
2020 466 466
2021 550 550
2022 298 298

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 759 759
Break 419 419
Scratched Material 162 162
Appropriate Term/Code Not Available 160 160
Unintended Movement 144 144
Failure to Cut 143 143
Material Deformation 137 137
Naturally Worn 129 129
Loose or Intermittent Connection 128 128
Material Twisted/Bent 102 102
Difficult to Advance 88 88
Connection Problem 82 82
Adverse Event Without Identified Device or Use Problem 68 68
Fracture 65 65
Dull, Blunt 51 51
Structural Problem 43 43
Physical Resistance/Sticking 38 38
Component Missing 35 35
Inadequacy of Device Shape and/or Size 34 34
Device Slipped 30 30
Mechanical Jam 29 29
Contamination /Decontamination Problem 27 27
Crack 20 20
Illegible Information 19 19
Fitting Problem 18 18
Bent 16 16
Entrapment of Device 14 14
Material Integrity Problem 14 14
Difficult to Remove 13 13
Device Damaged Prior to Use 12 12
Insufficient Information 12 12
Chemical Problem 11 11
Difficult to Open or Close 11 11
Device Dislodged or Dislocated 6 6
Device Markings/Labelling Problem 6 6
Positioning Problem 6 6
Defective Device 6 6
Mechanical Problem 6 6
Difficult to Insert 5 5
Incomplete or Inadequate Connection 4 4
Device Operates Differently Than Expected 4 4
Device Contamination with Chemical or Other Material 4 4
Device Damaged by Another Device 3 3
Detachment of Device or Device Component 3 3
Use of Device Problem 3 3
Device Issue 3 3
Misconnection 3 3
Corroded 2 2
Disassembly 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Failure to Advance 2 2
Off-Label Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Separation Problem 2 2
Failure to Clean Adequately 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Compatibility Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Sticking 1 1
Solder Joint Fracture 1 1
Dent in Material 1 1
Failure to Disconnect 1 1
Material Discolored 1 1
Material Disintegration 1 1
Positioning Failure 1 1
Backflow 1 1
Loss of or Failure to Bond 1 1
Difficult To Position 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1188 1188
No Clinical Signs, Symptoms or Conditions 778 778
No Code Available 172 172
No Information 131 131
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 88 88
Not Applicable 77 77
Bone Fracture(s) 36 36
Limb Fracture 10 10
Unspecified Tissue Injury 9 9
Pain 7 7
Joint Dislocation 6 6
No Patient Involvement 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Joint Laxity 3 3
Unspecified Infection 3 3
Hip Fracture 2 2
Discomfort 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Inadequate Osseointegration 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Thrombosis/Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II May-09-2017
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