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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device gauge, depth
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

MDR Year MDR Reports MDR Events
2019 196 196
2020 354 354
2021 403 403
2022 316 316
2023 376 376
2024 164 164

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1033 1033
Material Deformation 421 421
Mechanical Jam 108 108
Device-Device Incompatibility 72 72
Incorrect Measurement 46 46
Use of Device Problem 36 36
Material Twisted/Bent 32 32
Fracture 29 29
Mechanical Problem 22 22
Material Integrity Problem 20 20
Detachment of Device or Device Component 19 19
Naturally Worn 16 16
Illegible Information 12 12
Component Missing 11 11
Device Slipped 9 9
Appropriate Term/Code Not Available 8 8
Entrapment of Device 7 7
Crack 7 7
Material Discolored 7 7
No Apparent Adverse Event 7 7
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Cut 4 4
Defective Device 4 4
Degraded 4 4
Unintended Movement 2 2
Separation Failure 2 2
Output Problem 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Disconnection 1 1
Misassembled 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Fragmentation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1251 1251
No Consequences Or Impact To Patient 269 269
No Patient Involvement 208 208
Insufficient Information 61 61
No Code Available 11 11
Foreign Body In Patient 10 10
No Known Impact Or Consequence To Patient 10 10
Not Applicable 2 2
No Information 2 2
Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Pneumothorax 1 1

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