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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
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 252 252

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1320 1320
Material Deformation 437 437
Mechanical Jam 129 129
Device-Device Incompatibility 74 74
Incorrect Measurement 67 67
Fracture 42 42
Material Fragmentation 41 41
Use of Device Problem 36 36
Material Twisted/Bent 35 35
Component Missing 35 35
Detachment of Device or Device Component 28 28
Device Operates Differently Than Expected 25 25
Naturally Worn 25 25
Mechanical Problem 23 23
Material Integrity Problem 20 20
Illegible Information 17 17
Bent 16 16
Appropriate Term/Code Not Available 11 11
Device Slipped 9 9
Sticking 8 8
Entrapment of Device 8 8
Crack 7 7
No Apparent Adverse Event 7 7
Material Discolored 7 7
Fitting Problem 6 6
Defective Device 5 5
Device Reprocessing Problem 4 4
Difficult to Remove 4 4
Degraded 4 4
Failure to Align 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Cut 4 4
Output Problem 3 3
Material Separation 3 3
Device Markings/Labelling Problem 3 3
Particulates 3 3
Difficult To Position 2 2
Calibration Problem 2 2
Misassembled 2 2
Separation Failure 2 2
Unintended Movement 2 2
Packaging Problem 1 1
Device Damaged by Another Device 1 1
Insufficient Information 1 1
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Too Rigid or Stiff 1 1
Component Misassembled 1 1
Positioning Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1334 1334
No Patient Involvement 379 379
No Consequences Or Impact To Patient 320 320
No Known Impact Or Consequence To Patient 131 131
Insufficient Information 66 66
No Code Available 22 22
No Information 16 16
Foreign Body In Patient 11 11
Not Applicable 3 3
Device Embedded In Tissue or Plaque 3 3
Failure of Implant 2 2
Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Bone Fracture(s) 1 1
Blood Loss 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Sedation 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Jul-04-2019
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