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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device screw, fixation, intraosseous
Product CodeDZL
Regulation Number 872.4880
Device Class 2


Premarket Reviews
ManufacturerDecision
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAGER & MEISINGER GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTRA-LOCK INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOBIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOSS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD..
  SUBSTANTIALLY EQUIVALENT 1
SALVIN DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 74 74
2018 57 57
2019 50 50
2020 85 85
2021 55 55
2022 162 162
2023 100 100
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 244 244
Fracture 85 85
Adverse Event Without Identified Device or Use Problem 78 78
Physical Resistance/Sticking 44 44
Patient Device Interaction Problem 41 41
Mechanical Jam 23 23
Material Fragmentation 11 11
Nonstandard Device 10 10
Entrapment of Device 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Material Twisted/Bent 9 9
Unintended Movement 8 8
Difficult to Advance 7 7
Use of Device Problem 5 5
Signal Artifact/Noise 5 5
Migration 5 5
Naturally Worn 4 4
Improper or Incorrect Procedure or Method 4 4
Patient-Device Incompatibility 4 4
Detachment of Device or Device Component 4 4
Device Dislodged or Dislocated 3 3
Off-Label Use 3 3
Crack 3 3
Migration or Expulsion of Device 3 3
Difficult to Remove 2 2
Retraction Problem 2 2
Material Rupture 2 2
Detachment Of Device Component 2 2
Material Deformation 2 2
Device-Device Incompatibility 2 2
Difficult or Delayed Activation 2 2
Failure to Fire 2 2
Activation Failure 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Firing Problem 2 2
Premature Separation 1 1
Failure to Eject 1 1
Noise, Audible 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Malposition of Device 1 1
Defective Device 1 1
Component Missing 1 1
Failure to Align 1 1
Device Operates Differently Than Expected 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Component Falling 1 1
Bent 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Device Slipped 1 1
Misassembled 1 1
Difficult or Delayed Positioning 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 201 201
No Consequences Or Impact To Patient 78 78
Foreign Body In Patient 60 60
No Known Impact Or Consequence To Patient 60 60
No Information 43 43
No Code Available 35 35
Insufficient Information 31 31
Unspecified Infection 24 24
Device Embedded In Tissue or Plaque 18 18
Non-union Bone Fracture 16 16
Discomfort 15 15
Failure of Implant 14 14
Pain 12 12
Hypersensitivity/Allergic reaction 8 8
Unspecified Musculoskeletal problem 8 8
Nerve Damage 8 8
No Patient Involvement 6 6
Fatigue 5 5
Injury 4 4
Loss of consciousness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Impaired Healing 2 2
Difficulty Chewing 2 2
Physical Asymmetry 2 2
Swelling/ Edema 2 2
Post Operative Wound Infection 2 2
Sleep Dysfunction 2 2
Loss of Range of Motion 2 2
Ossification 2 2
Host-Tissue Reaction 1 1
Bone Fracture(s) 1 1
Inflammation 1 1
Increased Sensitivity 1 1
Tissue Damage 1 1
Sedation 1 1
Limited Mobility Of The Implanted Joint 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Reaction 1 1
Tooth Fracture 1 1

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