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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Product CodeLXT
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2018 73 73
2019 40 40
2020 32 32
2021 24 24
2022 21 21
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29 29
Adverse Event Without Identified Device or Use Problem 24 24
Packaging Problem 23 23
Manufacturing, Packaging or Shipping Problem 23 23
Migration 15 15
Appropriate Term/Code Not Available 12 12
Mechanical Problem 11 11
Device Contaminated During Manufacture or Shipping 8 8
Device-Device Incompatibility 7 7
Migration or Expulsion of Device 7 7
Fracture 6 6
Difficult to Insert 5 5
Connection Problem 5 5
Device Packaging Compromised 5 5
Device Contamination with Chemical or Other Material 5 5
Device Markings/Labelling Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Crack 3 3
Delivered as Unsterile Product 3 3
Unsealed Device Packaging 3 3
Material Deformation 3 3
Shipping Damage or Problem 2 2
Loss of Osseointegration 1 1
Separation Failure 1 1
Malposition of Device 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Positioning Failure 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Positioning Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 60 60
No Known Impact Or Consequence To Patient 30 30
No Code Available 29 29
No Clinical Signs, Symptoms or Conditions 21 21
Failure of Implant 18 18
Pain 10 10
Unspecified Infection 9 9
No Consequences Or Impact To Patient 6 6
Non-union Bone Fracture 6 6
No Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body In Patient 3 3
Impaired Healing 2 2
Injury 2 2
Loss of Range of Motion 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Post Operative Wound Infection 1 1
Osteolysis 1 1
Osteopenia/ Osteoporosis 1 1
Fluid Discharge 1 1
Physical Asymmetry 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. II Jun-28-2022
2 Zimmer Biomet, Inc. II Jan-10-2019
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