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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
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
2021 55 56
2022 162 162
2023 100 100
2024 106 106
2025 71 71
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 217 217
Fracture 63 64
Adverse Event Without Identified Device or Use Problem 53 53
Patient Device Interaction Problem 42 42
Physical Resistance/Sticking 34 34
Entrapment of Device 29 29
Material Twisted/Bent 18 18
Mechanical Jam 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Nonstandard Device 10 10
Crack 8 8
Signal Artifact/Noise 5 5
Migration 5 5
Off-Label Use 3 3
Difficult to Advance 3 3
Material Deformation 3 3
Detachment of Device or Device Component 3 3
Device Dislodged or Dislocated 3 3
Migration or Expulsion of Device 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Device Damaged by Another Device 2 2
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 1 1
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Failure to Align 1 1
Failure to Cut 1 1
Misassembled 1 1
Failure to Fire 1 1
Component Misassembled 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 312 312
Foreign Body In Patient 74 75
Insufficient Information 45 45
Discomfort 16 16
Non-union Bone Fracture 15 15
Failure of Implant 14 14
Nerve Damage 9 9
Hypersensitivity/Allergic reaction 8 8
Unspecified Musculoskeletal problem 8 8
No Information 7 7
Pain 7 7
Unspecified Infection 6 6
Fatigue 4 4
Loss of consciousness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Consequences Or Impact To Patient 3 3
Unspecified Tissue Injury 2 2
Physical Asymmetry 2 2
Impaired Healing 1 1
Inflammation 1 1
Post Operative Wound Infection 1 1
Fluid Discharge 1 1
Extravasation 1 1
Swelling/ Edema 1 1
Fistula 1 1

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