Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device appliance, fixation, nail/blade/plate combination, multiple component, metal composite
Product CodeLXT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
NEW PARADIGM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 40 40
2020 32 32
2021 24 24
2022 21 21
2023 18 18
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 29 29
Break 23 23
Mechanical Problem 20 20
Migration 14 14
Device-Device Incompatibility 13 13
Appropriate Term/Code Not Available 12 12
Packaging Problem 8 8
Migration or Expulsion of Device 7 7
Connection Problem 5 5
Tear, Rip or Hole in Device Packaging 4 4
Difficult to Insert 4 4
Material Deformation 4 4
Crack 3 3
Fracture 3 3
Shipping Damage or Problem 2 2
Device Slipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Peeled/Delaminated 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Unsealed Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment of Device or Device Component 1 1
Loss of Osseointegration 1 1
Difficult to Remove 1 1
Material Twisted/Bent 1 1
Material Too Rigid or Stiff 1 1
Delivered as Unsterile Product 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Code Available 24 24
No Known Impact Or Consequence To Patient 24 24
Failure of Implant 17 17
No Patient Involvement 13 13
Pain 9 9
Non-union Bone Fracture 9 9
Unspecified Infection 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Consequences Or Impact To Patient 5 5
Insufficient Information 4 4
Post Operative Wound Infection 2 2
Injury 2 2
Loss of Range of Motion 2 2
Unspecified Tissue Injury 2 2
Impaired Healing 1 1
Skin Infection 1 1
Bone Fracture(s) 1 1
Osteopenia/ Osteoporosis 1 1
Foreign Body In Patient 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Discomfort 1 1
Osteolysis 1 1
Fluid Discharge 1 1
Physical Asymmetry 1 1
Hemorrhage/Bleeding 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
-
-