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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device screw, fixation, intraosseous
Product CodeDZL
Regulation Number 872.4880
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET SPORTS MEDICINE
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELI-KA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HAGER & MEISINGER GMBH
  SUBSTANTIALLY EQUIVALENT 4
INTRA-LOCK INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
MILTEX, 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
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
SALVIN DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
SALVIN DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 106 106
2015 103 103
2016 34 34
2017 74 74
2018 57 57
2019 50 50
2020 85 85
2021 55 55
2022 162 162
2023 100 100
2024 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Break 396 396
Adverse Event Without Identified Device or Use Problem 168 168
Fracture 98 98
Physical Resistance/Sticking 47 47
Patient Device Interaction Problem 41 41
Material Fragmentation 31 31
Mechanical Jam 23 23
Entrapment of Device 21 21
Unintended Movement 16 16
Material Twisted/Bent 12 12
Loose or Intermittent Connection 10 10
Nonstandard Device 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Difficult to Remove 9 9
Detachment Of Device Component 8 8
Difficult to Advance 8 8
Migration or Expulsion of Device 7 7
Failure to Advance 7 7
Device Dislodged or Dislocated 6 6
Migration 5 5
Detachment of Device or Device Component 5 5
Use of Device Problem 5 5
Signal Artifact/Noise 5 5
Patient-Device Incompatibility 5 5
Difficult to Insert 4 4
Improper or Incorrect Procedure or Method 4 4
Naturally Worn 4 4
Device Operates Differently Than Expected 4 4
Insufficient Information 3 3
Material Deformation 3 3
Crack 3 3
Off-Label Use 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Difficult or Delayed Activation 2 2
Device-Device Incompatibility 2 2
Bent 2 2
Material Rupture 2 2
Firing Problem 2 2
Retraction Problem 2 2
Failure to Fire 2 2
Activation Failure 2 2
Noise, Audible 1 1
Hole In Material 1 1
Component Falling 1 1
Device Slipped 1 1
Premature Separation 1 1
Device Or Device Fragments Location Unknown 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 249 249
No Known Impact Or Consequence To Patient 137 137
No Consequences Or Impact To Patient 83 83
Foreign Body In Patient 81 81
Unspecified Infection 80 80
No Code Available 67 67
Device Embedded In Tissue or Plaque 55 55
No Information 46 46
Insufficient Information 39 39
Impaired Healing 25 25
Sedation 23 23
Pain 21 21
Failure of Implant 19 19
Non-union Bone Fracture 16 16
Discomfort 15 15
Hypersensitivity/Allergic reaction 8 8
Unspecified Musculoskeletal problem 8 8
Nerve Damage 8 8
Airway Obstruction 7 7
No Patient Involvement 6 6
Staphylococcus Aureus 5 5
Fatigue 5 5
Injury 4 4
Loss of consciousness 4 4
Bone Fracture(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Post Operative Wound Infection 2 2
Ossification 2 2
Loss of Range of Motion 2 2
Inflammation 2 2
Swelling/ Edema 2 2
Physical Asymmetry 2 2
Pressure Sores 2 2
Difficulty Chewing 2 2
Sleep Dysfunction 2 2
Irritation 1 1
Tooth Fracture 1 1
Limited Mobility Of The Implanted Joint 1 1
Eye Injury 1 1
Reaction 1 1
Fluid Discharge 1 1
Decreased Sensitivity 1 1
Host-Tissue Reaction 1 1
Tissue Damage 1 1
Complaint, Ill-Defined 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i, LLC II Jul-06-2010
2 Biomet Microfixation, Inc. III Aug-11-2010
3 Synthes (USA) Products LLC II Apr-05-2016
4 Synthes USA HQ, Inc. II Jul-17-2013
5 Synthes USA HQ, Inc. II Mar-01-2013
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