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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
Regulation Description Intraosseous fixation screw or wire.
Product CodeDZL
Regulation Number 872.4880
Device Class 2


Premarket Reviews
ManufacturerDecision
ELI-KA TECHNOLOGIES
  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

MDR Year MDR Reports MDR Events
2016 34 34
2017 74 74
2018 57 57
2019 50 50
2020 85 85
2021 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Break 149 149
Fracture 58 58
Adverse Event Without Identified Device or Use Problem 36 36
Physical Resistance/Sticking 24 24
Material Fragmentation 19 19
Mechanical Jam 16 16
Unintended Movement 9 9
Difficult to Advance 5 5
Detachment Of Device Component 5 5
Use of Device Problem 5 5
Difficult to Remove 4 4
Naturally Worn 4 4
Patient-Device Incompatibility 3 3
Migration or Expulsion of Device 3 3
Loose or Intermittent Connection 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 2 2
Activation Failure 2 2
Firing Problem 2 2
Material Rupture 2 2
Improper or Incorrect Procedure or Method 2 2
Difficult or Delayed Activation 2 2
Device-Device Incompatibility 2 2
Retraction Problem 2 2
Detachment of Device or Device Component 2 2
Insufficient Information 2 2
Material Twisted/Bent 2 2
Bent 1 1
Noise, Audible 1 1
Failure to Eject 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Device Slipped 1 1
Component Missing 1 1
Crack 1 1
Material Disintegration 1 1
Failure to Fire 1 1
Malposition of Device 1 1
Component Falling 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 78 78
No Known Impact Or Consequence To Patient 67 67
No Code Available 46 46
No Information 45 45
Device Embedded In Tissue or Plaque 30 30
Foreign Body In Patient 21 21
Unspecified Infection 21 21
No Clinical Signs, Symptoms or Conditions 19 19
Pain 12 12
No Patient Involvement 6 6
Failure of Implant 6 6
Injury 4 4
Difficulty Chewing 2 2
Ossification 2 2
Impaired Healing 2 2
Loss of Range of Motion 2 2
Sleep Dysfunction 2 2
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Physical Asymmetry 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Increased Sensitivity 1 1
Sedation 1 1
Inflammation 1 1
Host-Tissue Reaction 1 1
Fatigue 1 1
Reaction 1 1
Tooth Fracture 1 1
Post Operative Wound Infection 1 1
Bone Fracture(s) 1 1
Tissue Damage 1 1
Limited Mobility Of The Implanted Joint 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Apr-05-2016
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