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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2016 73 73
2017 225 225
2018 433 433
2019 460 460
2020 347 347

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 403 403
Break 288 288
Appropriate Term/Code Not Available 166 166
Loose or Intermittent Connection 129 129
Scratched Material 120 120
Naturally Worn 87 87
Connection Problem 83 83
Material Deformation 80 80
Unintended Movement 74 74
Material Twisted/Bent 62 62
Fracture 53 53
Dull, Blunt 51 51
Physical Resistance/Sticking 37 37
Inadequacy of Device Shape and/or Size 34 34
Component Missing 34 34
Failure to Cut 30 30
Device Slipped 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Fitting Problem 21 21
Bent 20 20
Crack 19 19
Mechanical Jam 17 17
Insufficient Information 16 16
Mechanical Problem 14 14
Difficult to Remove 12 12
Entrapment of Device 8 8
Structural Problem 7 7
Device Markings/Labelling Problem 6 6
Difficult to Insert 5 5
Positioning Problem 5 5
Device Operates Differently Than Expected 5 5
Device Issue 4 4
Device Contamination with Chemical or Other Material 4 4
Incomplete or Inadequate Connection 4 4
Misconnection 4 4
Contamination /Decontamination Problem 4 4
Material Integrity Problem 3 3
Defective Device 3 3
Detachment of Device or Device Component 3 3
Difficult to Open or Close 3 3
Device Damaged by Another Device 2 2
Separation Problem 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Disassembly 2 2
Failure to Advance 2 2
Device Damaged Prior to Use 2 2
Solder Joint Fracture 1 1
Sticking 1 1
Dent in Material 1 1
Failure to Disconnect 1 1
Material Discolored 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Clean Adequately 1 1
Device Subassembly 1 1
Migration 1 1
Material Disintegration 1 1
Difficult To Position 1 1
Positioning Failure 1 1
Loss of or Failure to Bond 1 1
Use of Device Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1143 1143
No Information 146 146
No Code Available 141 141
No Known Impact Or Consequence To Patient 133 133
Not Applicable 73 73
Bone Fracture(s) 26 26
No Patient Involvement 6 6
Pain 5 5
Hip Fracture 2 2
Inadequate Osseointegration 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Infection 1 1
Damage to Ligament(s) 1 1

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