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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
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
2017 74 74
2018 57 57
2019 50 50
2020 85 85
2021 55 55
2022 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Break 160 160
Fracture 65 65
Adverse Event Without Identified Device or Use Problem 50 50
Physical Resistance/Sticking 33 33
Mechanical Jam 20 20
Material Fragmentation 11 11
Unintended Movement 8 8
Difficult to Advance 5 5
Use of Device Problem 5 5
Naturally Worn 4 4
Material Twisted/Bent 4 4
Entrapment of Device 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 3 3
Difficult or Delayed Activation 2 2
Failure to Fire 2 2
Improper or Incorrect Procedure or Method 2 2
Material Deformation 2 2
Device Dislodged or Dislocated 2 2
Device-Device Incompatibility 2 2
Migration or Expulsion of Device 2 2
Difficult to Remove 2 2
Retraction Problem 2 2
Material Rupture 2 2
Detachment Of Device Component 2 2
Crack 2 2
Activation Failure 2 2
Firing Problem 2 2
Noise, Audible 1 1
Failure to Eject 1 1
Insufficient Information 1 1
Difficult or Delayed Positioning 1 1
Material Disintegration 1 1
Component Falling 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Device Slipped 1 1
Misassembled 1 1
Bent 1 1
Device Contaminated During Manufacture or Shipping 1 1
Component Missing 1 1
Failure to Align 1 1
Malposition of Device 1 1
Device Operates Differently Than Expected 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 60 60
No Clinical Signs, Symptoms or Conditions 60 60
Foreign Body In Patient 44 44
No Information 43 43
No Code Available 35 35
Unspecified Infection 19 19
Device Embedded In Tissue or Plaque 18 18
Non-union Bone Fracture 15 15
Pain 11 11
No Patient Involvement 6 6
Failure of Implant 5 5
Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Sleep Dysfunction 2 2
Ossification 2 2
Loss of Range of Motion 2 2
Difficulty Chewing 2 2
Impaired Healing 2 2
Reaction 1 1
Tooth Fracture 1 1
Post Operative Wound Infection 1 1
Limited Mobility Of The Implanted Joint 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Increased Sensitivity 1 1
Tissue Damage 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Host-Tissue Reaction 1 1
Sedation 1 1
Physical Asymmetry 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1

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