Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 instrument, cutting, orthopedic
Product CodeHTZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 47 47
2019 109 109
2020 87 87
2021 229 229
2022 196 196
2023 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Break 277 277
Device-Device Incompatibility 193 193
Material Deformation 106 106
Naturally Worn 91 91
Material Twisted/Bent 42 42
Scratched Material 35 35
Mechanical Jam 32 32
Corroded 29 29
Physical Resistance/Sticking 22 22
Crack 21 21
Material Integrity Problem 18 18
Contamination /Decontamination Problem 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Mechanical Problem 11 11
Detachment of Device or Device Component 10 10
Illegible Information 9 9
Activation, Positioning or Separation Problem 8 8
Failure to Cut 6 6
Difficult to Remove 5 5
Material Frayed 5 5
Loose or Intermittent Connection 4 4
Entrapment of Device 4 4
Appropriate Term/Code Not Available 4 4
Connection Problem 3 3
Patient-Device Incompatibility 2 2
Material Discolored 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Issue 2 2
Structural Problem 2 2
Failure to Disconnect 2 2
Device Damaged by Another Device 2 2
Sharp Edges 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Positioning Problem 1 1
Component Missing 1 1
Material Separation 1 1
Device Slipped 1 1
Off-Label Use 1 1
Display Difficult to Read 1 1
Incorrect Measurement 1 1
Degraded 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 561 561
No Consequences Or Impact To Patient 163 163
Insufficient Information 31 31
No Patient Involvement 23 23
No Known Impact Or Consequence To Patient 17 17
No Code Available 15 15
Not Applicable 14 14
Foreign Body In Patient 3 3
Unspecified Tissue Injury 3 3
Pain 2 2
Post Operative Wound Infection 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Nerve Damage 1 1
Failure of Implant 1 1
Injury 1 1
Disability 1 1
Joint Dislocation 1 1
Spinal Cord Injury 1 1
Cerebrospinal Fluid Leakage 1 1
Paralysis 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Feb-13-2020
-
-