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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
2018 447 447
2019 535 535
2020 734 734
2021 794 794
2022 581 581
2023 675 675

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1412 1412
Break 897 897
Material Deformation 293 293
Adverse Event Without Identified Device or Use Problem 229 229
Material Twisted/Bent 196 196
Fracture 186 186
Device Contaminated During Manufacture or Shipping 97 97
Mechanical Jam 96 96
Entrapment of Device 59 59
Failure to Align 56 56
Material Integrity Problem 47 47
Use of Device Problem 44 44
Packaging Problem 40 40
Unstable 38 38
Device Operates Differently Than Expected 34 34
Detachment of Device or Device Component 30 30
Component Missing 21 21
Material Separation 20 20
Mechanical Problem 19 19
Appropriate Term/Code Not Available 18 18
Connection Problem 17 17
Contamination /Decontamination Problem 15 15
Device Difficult to Maintain 15 15
Tear, Rip or Hole in Device Packaging 14 14
Corroded 14 14
Degraded 14 14
Device Markings/Labelling Problem 13 13
Physical Resistance/Sticking 13 13
Fitting Problem 12 12
Defective Device 11 11
Crack 11 11
Difficult to Remove 10 10
Bent 9 9
Device Slipped 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Incomplete or Inadequate Connection 9 9
Compatibility Problem 8 8
Separation Failure 8 8
Loose or Intermittent Connection 8 8
Improper or Incorrect Procedure or Method 7 7
Device Handling Problem 7 7
Naturally Worn 7 7
No Apparent Adverse Event 6 6
Dull, Blunt 6 6
Incorrect Measurement 6 6
Unsealed Device Packaging 5 5
Peeled/Delaminated 5 5
Material Fragmentation 5 5
Device Operational Issue 5 5
Insufficient Information 5 5
Scratched Material 5 5
Unintended Movement 4 4
Device Packaging Compromised 4 4
Failure to Cut 4 4
Positioning Failure 4 4
Disassembly 4 4
Failure To Adhere Or Bond 3 3
Difficult to Insert 3 3
Delivered as Unsterile Product 3 3
Difficult to Advance 3 3
Difficult or Delayed Separation 3 3
Patient Device Interaction Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Misassembled During Installation 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Device Damaged by Another Device 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Component or Accessory Incompatibility 2 2
Malposition of Device 2 2
Device Damaged Prior to Use 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 2 2
Misassembled 2 2
Labelling, Instructions for Use or Training Problem 2 2
Detachment Of Device Component 2 2
Accessory Incompatible 1 1
Material Discolored 1 1
Flaked 1 1
Product Quality Problem 1 1
No Device Output 1 1
Overheating of Device 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Residue After Decontamination 1 1
Metal Shedding Debris 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Installation-Related Problem 1 1
Inaccurate Information 1 1
Unintended Compatibility 1 1
Noise, Audible 1 1
Sharp Edges 1 1
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
Physical Property Issue 1 1
Positioning Problem 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1844 1844
No Consequences Or Impact To Patient 784 784
No Patient Involvement 390 390
No Known Impact Or Consequence To Patient 197 197
No Code Available 148 148
Foreign Body In Patient 104 104
Unspecified Infection 87 87
Joint Laxity 78 78
Insufficient Information 74 74
Injury 37 37
No Information 34 34
Not Applicable 24 24
Implant Pain 22 22
Failure of Implant 14 14
Device Embedded In Tissue or Plaque 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Unspecified Tissue Injury 10 10
Tissue Damage 7 7
Bone Fracture(s) 6 6
Pain 5 5
Loss of Range of Motion 4 4
Scar Tissue 2 2
Swelling 2 2
Numbness 2 2
Hypersensitivity/Allergic reaction 2 2
Inflammation 2 2
Fall 2 2
Foreign Body Reaction 1 1
Hemorrhage, Subarachnoid 1 1
Abrasion 1 1
Awareness during Anaesthesia 1 1
Burn(s) 1 1
Death 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Perforation 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Arthralgia 1 1
Joint Dislocation 1 1
Rupture 1 1
Brain Injury 1 1
Inadequate Osseointegration 1 1
Swelling/ Edema 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Cramp(s) /Muscle Spasm(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes, Inc. II Feb-21-2018
2 Zimmer Biomet, Inc. II Nov-22-2019
3 Zimmer Biomet, Inc. II Apr-20-2018
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