• 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 impactor
Product CodeHWA
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2018 1609 1609
2019 1550 1550
2020 1477 1477
2021 2006 2006
2022 2088 2088
2023 1557 1557

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7370 7370
Crack 997 997
Naturally Worn 666 666
Fracture 586 586
Device-Device Incompatibility 550 550
Material Twisted/Bent 336 336
Material Deformation 176 176
Scratched Material 174 174
Contamination /Decontamination Problem 146 146
Material Integrity Problem 104 104
Adverse Event Without Identified Device or Use Problem 71 71
Mechanical Jam 70 70
No Apparent Adverse Event 67 67
Appropriate Term/Code Not Available 55 55
Detachment of Device or Device Component 52 52
Unintended Movement 46 46
Component Missing 38 38
Loose or Intermittent Connection 37 37
Entrapment of Device 32 32
Illegible Information 25 25
Physical Resistance/Sticking 24 24
Device Contamination with Chemical or Other Material 21 21
Material Discolored 20 20
Failure to Disconnect 19 19
Connection Problem 19 19
Mechanical Problem 16 16
Device Slipped 12 12
Dull, Blunt 12 12
Difficult to Remove 11 11
Use of Device Problem 9 9
Insufficient Information 8 8
Structural Problem 7 7
Material Fragmentation 7 7
Corroded 6 6
Off-Label Use 6 6
Device Damaged by Another Device 6 6
Compatibility Problem 6 6
Device Dislodged or Dislocated 5 5
Defective Device 5 5
Deformation Due to Compressive Stress 5 5
Fitting Problem 5 5
Disassembly 5 5
Device Reprocessing Problem 5 5
Flaked 4 4
Defective Component 4 4
Device Issue 4 4
Material Split, Cut or Torn 4 4
Separation Problem 4 4
Positioning Problem 3 3
Device Damaged Prior to Use 3 3
Delivered as Unsterile Product 3 3
Degraded 3 3
Bent 3 3
Detachment Of Device Component 2 2
Difficult to Insert 2 2
Material Rupture 2 2
Material Disintegration 2 2
Improper or Incorrect Procedure or Method 2 2
Problem with Sterilization 2 2
Failure to Cut 2 2
Device Difficult to Maintain 2 2
Osseointegration Problem 2 2
Failure to Clean Adequately 2 2
Difficult or Delayed Separation 1 1
Missing Information 1 1
Device Fell 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1
Device Or Device Fragments Location Unknown 1 1
Blocked Connection 1 1
Activation, Positioning or Separation Problem 1 1
Separation Failure 1 1
Loss of Osseointegration 1 1
Solder Joint Fracture 1 1
Residue After Decontamination 1 1
Material Separation 1 1
Product Quality Problem 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Disconnection 1 1
Accessory Incompatible 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5561 5561
No Consequences Or Impact To Patient 3980 3980
Insufficient Information 276 276
No Code Available 199 199
No Known Impact Or Consequence To Patient 187 187
Not Applicable 107 107
No Patient Involvement 89 89
No Information 49 49
Foreign Body In Patient 40 40
Device Embedded In Tissue or Plaque 8 8
Unspecified Infection 7 7
Pain 6 6
Injury 4 4
Failure of Implant 4 4
Bone Fracture(s) 3 3
Inadequate Osseointegration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Musculoskeletal problem 1 1
Osteopenia/ Osteoporosis 1 1
Patient Problem/Medical Problem 1 1
Hematoma 1 1
Thrombosis 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Enztec Limited II Jan-24-2020
2 Exactech, Inc. II Jun-30-2023
3 Exactech, Inc. II Sep-10-2019
4 XTANT Medical II Jul-04-2020
5 Zimmer Biomet, Inc. II Feb-14-2018
-
-