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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
BIOMET SPORTS MEDICINE
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELI-KA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HAGER & MEISINGER GMBH
  SUBSTANTIALLY EQUIVALENT 3
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
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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 351 351
Adverse Event Without Identified Device or Use Problem 168 168
Fracture 92 92
Physical Resistance/Sticking 44 44
Patient Device Interaction Problem 41 41
Material Fragmentation 31 31
Mechanical Jam 23 23
Unintended Movement 16 16
Entrapment of Device 11 11
Loose or Intermittent Connection 10 10
Nonstandard Device 10 10
Material Twisted/Bent 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Difficult to Remove 9 9
Detachment Of Device Component 8 8
Migration or Expulsion of Device 7 7
Failure to Advance 7 7
Difficult to Advance 7 7
Device Dislodged or Dislocated 6 6
Migration 5 5
Use of Device Problem 5 5
Patient-Device Incompatibility 5 5
Detachment of Device or Device Component 5 5
Signal Artifact/Noise 5 5
Difficult to Insert 4 4
Device Operates Differently Than Expected 4 4
Improper or Incorrect Procedure or Method 4 4
Naturally Worn 4 4
Insufficient Information 3 3
Off-Label Use 3 3
Crack 3 3
Bent 2 2
Retraction Problem 2 2
Material Rupture 2 2
Failure to Fire 2 2
Device-Device Incompatibility 2 2
Difficult or Delayed Activation 2 2
Activation Failure 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Deformation 2 2
Firing Problem 2 2
Premature Separation 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Positioning Problem 1 1
Failure to Eject 1 1
Noise, Audible 1 1
No Apparent Adverse Event 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Component Missing 1 1
Failure to Align 1 1
Malposition of Device 1 1
Material Separation 1 1
Device Slipped 1 1
Sticking 1 1
Misassembled 1 1
Component Falling 1 1
Difficult or Delayed Positioning 1 1
Material Disintegration 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 201 201
No Known Impact Or Consequence To Patient 137 137
No Consequences Or Impact To Patient 83 83
Unspecified Infection 80 80
Foreign Body In Patient 70 70
No Code Available 67 67
Device Embedded In Tissue or Plaque 55 55
No Information 46 46
Insufficient Information 31 31
Impaired Healing 25 25
Sedation 23 23
Pain 21 21
Failure of Implant 17 17
Non-union Bone Fracture 16 16
Discomfort 15 15
Nerve Damage 8 8
Hypersensitivity/Allergic reaction 8 8
Unspecified Musculoskeletal problem 8 8
Airway Obstruction 7 7
No Patient Involvement 6 6
Fatigue 5 5
Staphylococcus Aureus 5 5
Loss of consciousness 4 4
Injury 4 4
Bone Fracture(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Physical Asymmetry 2 2
Swelling/ Edema 2 2
Ossification 2 2
Pressure Sores 2 2
Loss of Range of Motion 2 2
Inflammation 2 2
Post Operative Wound Infection 2 2
Sleep Dysfunction 2 2
Difficulty Chewing 2 2
Limited Mobility Of The Implanted Joint 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Tooth Fracture 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Irritation 1 1
Increased Sensitivity 1 1
Tissue Damage 1 1
Host-Tissue Reaction 1 1
Eye Injury 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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