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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 735 735
2021 795 795
2022 591 591

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1198 1198
Break 763 763
Material Deformation 231 231
Fracture 175 175
Material Twisted/Bent 167 167
Device Contaminated During Manufacture or Shipping 97 97
Mechanical Jam 88 88
Entrapment of Device 53 53
Failure to Align 49 49
Packaging Problem 39 39
Use of Device Problem 38 38
Device Operates Differently Than Expected 34 34
Material Integrity Problem 31 31
Adverse Event Without Identified Device or Use Problem 27 27
Detachment of Device or Device Component 26 26
Component Missing 21 21
Mechanical Problem 19 19
Appropriate Term/Code Not Available 18 18
Connection Problem 17 17
Material Separation 16 16
Device Difficult to Maintain 15 15
Physical Resistance/Sticking 14 14
Corroded 14 14
Tear, Rip or Hole in Device Packaging 14 14
Device Markings/Labelling Problem 13 13
Degraded 13 13
Fitting Problem 12 12
Defective Device 11 11
Crack 10 10
Bent 9 9
Difficult to Remove 9 9
Incomplete or Inadequate Connection 9 9
Loose or Intermittent Connection 8 8
Compatibility Problem 8 8
Separation Failure 7 7
Device Handling Problem 7 7
Naturally Worn 6 6
Dull, Blunt 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Device Slipped 6 6
Incorrect Measurement 5 5
Unsealed Device Packaging 5 5
Peeled/Delaminated 5 5
Material Fragmentation 5 5
Device Operational Issue 5 5
Insufficient Information 5 5
Scratched Material 4 4
No Apparent Adverse Event 4 4
Device Packaging Compromised 4 4
Unintended Movement 4 4
Failure to Cut 4 4
Contamination /Decontamination Problem 4 4
Positioning Failure 4 4
Disassembly 4 4
Failure To Adhere Or Bond 3 3
Delivered as Unsterile Product 3 3
Difficult to Advance 3 3
Patient Device Interaction Problem 3 3
Difficult or Delayed Separation 3 3
Misassembled During Installation 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Damaged by Another Device 2 2
Malposition of Device 2 2
Device Damaged Prior to Use 2 2
Device Difficult to Setup or Prepare 2 2
Detachment Of Device Component 2 2
Difficult to Insert 2 2
Labelling, Instructions for Use or Training Problem 2 2
Flaked 1 1
Accessory Incompatible 1 1
Material Discolored 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Misassembled 1 1
No Device Output 1 1
Overheating of Device 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Metal Shedding Debris 1 1
Residue After Decontamination 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Component or Accessory Incompatibility 1 1
Installation-Related Problem 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Osseointegration Problem 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
Inaccurate Information 1 1
Unintended Compatibility 1 1
Noise, Audible 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1428 1428
No Consequences Or Impact To Patient 784 784
No Patient Involvement 390 390
No Known Impact Or Consequence To Patient 198 198
No Code Available 148 148
Foreign Body In Patient 92 92
Injury 37 37
No Information 34 34
Insufficient Information 26 26
Not Applicable 24 24
Device Embedded In Tissue or Plaque 12 12
Failure of Implant 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Unspecified Tissue Injury 8 8
Tissue Damage 7 7
Unspecified Infection 5 5
Pain 5 5
Bone Fracture(s) 4 4
Loss of Range of Motion 2 2
Scar Tissue 2 2
Swelling 2 2
Inflammation 2 2
Numbness 2 2
Blood Loss 1 1
Pseudoaneurysm 1 1
Inadequate Osseointegration 1 1
Swelling/ Edema 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Joint Laxity 1 1
Muscular Rigidity 1 1
Abrasion 1 1
Awareness during Anaesthesia 1 1
Burn(s) 1 1
Death 1 1
Foreign Body Reaction 1 1
Rupture 1 1
Brain Injury 1 1
Hemorrhage, Subarachnoid 1 1
Perforation 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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