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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 88 88

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1405 1405
Break 811 811
Material Deformation 325 325
Adverse Event Without Identified Device or Use Problem 293 293
Material Twisted/Bent 209 209
Fracture 178 178
Device Contaminated During Manufacture or Shipping 94 94
Mechanical Jam 74 74
Entrapment of Device 60 60
Unstable 57 57
Use of Device Problem 57 57
Material Integrity Problem 45 45
Packaging Problem 39 39
Detachment of Device or Device Component 29 29
Failure to Align 21 21
Component Missing 20 20
Material Separation 19 19
Connection Problem 17 17
Contamination /Decontamination Problem 16 16
Degraded 14 14
Appropriate Term/Code Not Available 14 14
Tear, Rip or Hole in Device Packaging 13 13
Corroded 12 12
Physical Resistance/Sticking 12 12
Mechanical Problem 11 11
Defective Device 11 11
Device Difficult to Maintain 10 10
Device Slipped 10 10
Crack 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Device Markings/Labelling Problem 9 9
Incomplete or Inadequate Connection 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
No Apparent Adverse Event 7 7
Scratched Material 6 6
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
Insufficient Information 4 4
Unintended Movement 4 4
Failure to Cut 4 4
Compatibility Problem 4 4
Difficult to Advance 3 3
Material Fragmentation 3 3
Difficult to Insert 3 3
Noise, Audible 3 3
Patient Device Interaction Problem 3 3
Difficult or Delayed Separation 3 3
Labelling, Instructions for Use or Training Problem 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 2 2
Device Damaged Prior to Use 2 2
Dull, Blunt 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
Positioning Problem 1 1
Osseointegration Problem 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1
Residue After Decontamination 1 1
Product Quality Problem 1 1
Accessory Incompatible 1 1
Unexpected Therapeutic Results 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
Unintended Compatibility 1 1
Misassembled During Installation 1 1
Inaccurate Information 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2000 2000
No Consequences Or Impact To Patient 585 585
No Patient Involvement 305 305
No Known Impact Or Consequence To Patient 118 118
Unspecified Infection 115 115
Insufficient Information 106 106
Joint Laxity 104 104
No Code Available 99 99
Foreign Body In Patient 92 92
Injury 36 36
Implant Pain 25 25
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
Device Embedded In Tissue or Plaque 9 9
Bone Fracture(s) 8 8
Loss of Range of Motion 6 6
Tissue Damage 6 6
Pain 5 5
Scar Tissue 2 2
Swelling 2 2
Inflammation 2 2
Hypersensitivity/Allergic reaction 2 2
Burn(s) 2 2
Fall 2 2
Numbness 2 2
Inadequate Osseointegration 1 1
Arthralgia 1 1
Joint Dislocation 1 1
Rupture 1 1
Brain Injury 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Abrasion 1 1
Awareness during Anaesthesia 1 1
Hemorrhage, Subarachnoid 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Perforation 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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