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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, rotary bone cutting
Regulation Description Bone cutting instrument and accessories.
Product CodeKMW
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 16 16
2019 13 13
2020 13 13
2021 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 70 70
Temperature Problem 29 29
Nonstandard Device 27 27
Improper or Incorrect Procedure or Method 3 3
Break 2 2
Use of Device Problem 2 2
Noise, Audible 2 2
Device Fell 1 1
Intermittent Loss of Power 1 1
Unintended Electrical Shock 1 1
Failure to Deliver Energy 1 1
Mechanical Problem 1 1
Material Too Rigid or Stiff 1 1
Smoking 1 1
Detachment of Device or Device Component 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 44 44
Injury 24 24
Burn, Thermal 22 22
Patient Problem/Medical Problem 20 20
Partial thickness (Second Degree) Burn 19 19
Superficial (First Degree) Burn 17 17
Erythema 2 2
Scarring 2 2
Swelling 2 2
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1
Unspecified Infection 1 1
Numbness 1 1
Foreign Body In Patient 1 1
Electric Shock 1 1
Full thickness (Third Degree) Burn 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Known Impact Or Consequence To Patient 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nakanishi Inc. II Oct-24-2018
2 Osteomed, LLC II Dec-06-2021
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