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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
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAGER& MEISINGER GMBH
  SUBSTANTIALLY EQUIVALENT 3
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
NEOSS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 85 85
2021 55 56
2022 162 162
2023 100 100
2024 106 106
2025 71 71
2026 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Break 240 240
Fracture 91 92
Adverse Event Without Identified Device or Use Problem 70 70
Physical Resistance/Sticking 52 52
Patient Device Interaction Problem 42 42
Entrapment of Device 30 30
Mechanical Jam 23 23
Material Twisted/Bent 19 19
Manufacturing, Packaging or Shipping Problem 14 14
Nonstandard Device 10 10
Crack 8 8
Difficult to Advance 8 8
Unintended Movement 7 7
Signal Artifact/Noise 5 5
Migration 5 5
Off-Label Use 3 3
Material Deformation 3 3
Detachment of Device or Device Component 3 3
Device Slipped 2 2
Migration or Expulsion of Device 2 2
Patient-Device Incompatibility 2 2
Improper or Incorrect Procedure or Method 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Difficult or Delayed Activation 2 2
Device Dislodged or Dislocated 2 2
Device Damaged by Another Device 2 2
Failure to Fire 2 2
No Apparent Adverse Event 2 2
Activation Failure 2 2
Noise, Audible 1 1
Loss of Osseointegration 1 1
Premature Separation 1 1
Device Appears to Trigger Rejection 1 1
Component Misassembled 1 1
Misassembled 1 1
Failure to Cut 1 1
Insufficient Device Problem Information 1 1
Failure to Align 1 1
Difficult to Remove 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Malposition of Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 336 336
Foreign Body In Patient 83 84
Insufficient Information 51 51
No Information 34 34
No Consequences Or Impact To Patient 29 29
Unspecified Infection 20 20
Discomfort 16 16
Nonunion/Delayed-union Bone Fracture 16 16
Failure of Implant 14 14
No Code Available 10 10
Hypersensitivity/Allergic reaction 9 9
Nerve Damage 9 9
Pain 9 9
Unspecified Musculoskeletal problem 8 8
No Known Impact Or Consequence To Patient 7 7
Fatigue 4 4
Loss of consciousness 4 4
Swelling/ Edema 3 3
Physical Asymmetry 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Post Operative Wound Infection 2 2
Injury 2 2
Fluid Discharge 2 2
Unspecified Tissue Injury 2 2
Fistula 2 2
Impaired Healing 1 1
Limited Mobility Of The Implanted Joint 1 1
Bone Fracture(s) 1 1
Inflammation 1 1
No Patient Involvement 1 1
Hyporesponsive to stimuli 1 1
Extravasation 1 1
Increased Sensitivity 1 1
Device Embedded In Tissue or Plaque 1 1

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