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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauge, depth
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

MDR Year MDR Reports MDR Events
2014 106 106
2015 139 139
2016 178 178
2017 82 82
2018 104 104
2019 196 196
2020 354 354
2021 403 403
2022 316 316
2023 376 376
2024 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1374 1374
Material Deformation 407 407
Mechanical Jam 130 130
Incorrect Measurement 75 75
Device-Device Incompatibility 70 70
Component Missing 59 59
Material Fragmentation 54 54
Device Operates Differently Than Expected 45 45
Fracture 37 37
Use of Device Problem 36 36
Material Twisted/Bent 34 34
Detachment of Device or Device Component 28 28
Sticking 23 23
Mechanical Problem 23 23
Material Integrity Problem 20 20
Naturally Worn 19 19
Bent 19 19
Illegible Information 12 12
Appropriate Term/Code Not Available 11 11
Device Slipped 10 10
Fitting Problem 9 9
Material Discolored 8 8
Entrapment of Device 7 7
Crack 7 7
No Apparent Adverse Event 7 7
Device Markings/Labelling Problem 5 5
Failure to Align 4 4
Defective Device 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Degraded 4 4
Device Reprocessing Problem 4 4
Misassembled 4 4
Difficult to Remove 4 4
Particulates 3 3
Detachment Of Device Component 3 3
Output Problem 3 3
Measurement System Incompatibility 3 3
Calibration Problem 2 2
Separation Failure 2 2
Unintended Movement 2 2
Display Difficult to Read 2 2
Difficult To Position 2 2
Material Separation 2 2
Dull, Blunt 2 2
Obstruction of Flow 1 1
Tear, Rip or Hole in Device Packaging 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Unstable 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Disconnection 1 1
Migration or Expulsion of Device 1 1
Component Falling 1 1
Disassembly 1 1
Failure To Adhere Or Bond 1 1
Insufficient Information 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Contamination /Decontamination Problem 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1196 1196
No Patient Involvement 511 511
No Consequences Or Impact To Patient 331 331
No Known Impact Or Consequence To Patient 227 227
Insufficient Information 49 49
No Code Available 24 24
No Information 18 18
Foreign Body In Patient 11 11
Device Embedded In Tissue or Plaque 5 5
Sedation 4 4
Not Applicable 3 3
Injury 2 2
Bone Fracture(s) 2 2
Failure of Implant 2 2
Laceration(s) 1 1
Undesired Nerve Stimulation 1 1
Pneumothorax 1 1
Loss of Range of Motion 1 1
Blood Loss 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Mar-31-2011
2 Stryker Howmedica Osteonics Corp. II Feb-19-2010
3 Zimmer Biomet, Inc. II Jul-04-2019
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