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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device guide, surgical, instrument
Product CodeFZX
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 535 535
2020 734 734
2021 794 794
2022 581 581
2023 840 840
2024 246 246

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1484 1484
Break 834 834
Material Deformation 333 333
Adverse Event Without Identified Device or Use Problem 328 328
Material Twisted/Bent 237 237
Fracture 184 184
Device Contaminated During Manufacture or Shipping 94 94
Mechanical Jam 78 78
Unstable 65 65
Entrapment of Device 62 62
Use of Device Problem 57 57
Material Integrity Problem 47 47
Packaging Problem 41 41
Detachment of Device or Device Component 31 31
Failure to Align 21 21
Component Missing 20 20
Material Separation 19 19
Contamination /Decontamination Problem 17 17
Connection Problem 17 17
Appropriate Term/Code Not Available 15 15
Degraded 14 14
Tear, Rip or Hole in Device Packaging 13 13
Device Slipped 12 12
Corroded 12 12
Physical Resistance/Sticking 12 12
Crack 11 11
Mechanical Problem 11 11
Defective Device 11 11
Device Difficult to Maintain 10 10
No Apparent Adverse Event 10 10
Incomplete or Inadequate Connection 9 9
Device Markings/Labelling Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Loose or Intermittent Connection 8 8
Fitting Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Difficult to Remove 7 7
Scratched Material 7 7
Separation Failure 6 6
Device Handling Problem 6 6
Naturally Worn 5 5
Unsealed Device Packaging 5 5
Positioning Failure 5 5
Incorrect Measurement 4 4
Peeled/Delaminated 4 4
Compatibility Problem 4 4
Unintended Movement 4 4
Failure to Cut 4 4
Insufficient Information 4 4
Difficult or Delayed Separation 3 3
Noise, Audible 3 3
Patient Device Interaction Problem 3 3
Difficult to Advance 3 3
Device Damaged Prior to Use 3 3
Material Fragmentation 3 3
Difficult to Insert 3 3
Labelling, Instructions for Use or Training Problem 2 2
Dull, Blunt 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Damaged by Another Device 2 2
Component or Accessory Incompatibility 2 2
Malposition of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Inaccurate Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Unintended Compatibility 1 1
Misassembled During Installation 1 1
Sharp Edges 1 1
Positioning Problem 1 1
Osseointegration Problem 1 1
Installation-Related Problem 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Product Quality Problem 1 1
Accessory Incompatible 1 1
Unexpected Therapeutic Results 1 1
Residue After Decontamination 1 1
Material Discolored 1 1
Flaked 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2104 2104
No Consequences Or Impact To Patient 585 585
No Patient Involvement 305 305
Insufficient Information 138 138
Unspecified Infection 133 133
No Known Impact Or Consequence To Patient 118 118
Joint Laxity 113 113
No Code Available 99 99
Foreign Body In Patient 95 95
Injury 36 36
Implant Pain 27 27
No Information 23 23
Not Applicable 18 18
Failure of Implant 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Unspecified Tissue Injury 11 11
Bone Fracture(s) 10 10
Device Embedded In Tissue or Plaque 9 9
Loss of Range of Motion 7 7
Tissue Damage 6 6
Pain 5 5
Inflammation 3 3
Muscle/Tendon Damage 3 3
Scar Tissue 2 2
Swelling 2 2
Hypersensitivity/Allergic reaction 2 2
Burn(s) 2 2
Fall 2 2
Joint Dislocation 2 2
Osteolysis 2 2
Numbness 2 2
Inadequate Osseointegration 1 1
Arthralgia 1 1
Rupture 1 1
Brain Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Abrasion 1 1
Awareness during Anaesthesia 1 1
Hemorrhage, Subarachnoid 1 1
Perforation 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Osteomyelitis 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-18-2024
2 Zimmer Biomet, Inc. II Nov-22-2019
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