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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device passer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 39 39
2018 64 64
2019 55 55
2020 171 171
2021 160 160

Device Problems MDRs with this Device Problem Events in those MDRs
Break 249 249
Material Separation 53 53
Mechanical Jam 31 31
Detachment of Device or Device Component 20 20
Failure to Advance 17 17
Mechanical Problem 16 16
Device Operates Differently Than Expected 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Detachment Of Device Component 9 9
Material Fragmentation 8 8
Physical Resistance/Sticking 8 8
Fracture 7 7
Insufficient Information 6 6
Device Dislodged or Dislocated 5 5
Material Integrity Problem 5 5
Misassembled 5 5
Bent 4 4
Material Deformation 4 4
No Apparent Adverse Event 4 4
Device Fell 4 4
Ejection Problem 4 4
Firing Problem 4 4
Material Split, Cut or Torn 3 3
Difficult to Open or Close 3 3
Device-Device Incompatibility 3 3
Positioning Failure 3 3
Entrapment of Device 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Failure to Fire 3 3
Activation, Positioning or SeparationProblem 3 3
Separation Failure 2 2
Unsealed Device Packaging 2 2
Component Falling 2 2
Device Packaging Compromised 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Contamination with Chemical or Other Material 2 2
Separation Problem 2 2
Inaccurate Information 1 1
Appropriate Term/Code Not Available 1 1
Output Problem 1 1
Unintended Movement 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Difficult to Advance 1 1
Device Operational Issue 1 1
Device Disinfection Or Sterilization Issue 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Difficult to Fold, Unfold or Collapse 1 1
Loss of or Failure to Bond 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Grounding Malfunction 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Expiration Date Error 1 1
Misfire 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Solder Joint Fracture 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 203 203
No Clinical Signs, Symptoms or Conditions 184 184
No Consequences Or Impact To Patient 42 42
No Information 21 21
Foreign Body In Patient 17 17
No Patient Involvement 9 9
Device Embedded In Tissue or Plaque 8 8
Injury 5 5
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 1 1
Pain 1 1
Scar Tissue 1 1
Tissue Damage 1 1
Chills 1 1

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