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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cover, burr hole
Regulation Description Burr hole cover.
Product CodeGXR
Regulation Number 882.5250
Device Class 2


Premarket Reviews
ManufacturerDecision
CHENDU MEDART MEDICAL SCIENTIFIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOS SURGERY S.L
  SUBSTANTIALLY EQUIVALENT 1
NEUROVENTION LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSAWARE BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 28 28
2022 13 13
2023 11 11
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Break 11 11
Difficult to Open or Close 7 7
Device Appears to Trigger Rejection 6 6
Insufficient Information 6 6
Human-Device Interface Problem 4 4
Unstable 4 4
Patient Device Interaction Problem 4 4
Unintended Movement 4 4
Mechanics Altered 2 2
Fracture 2 2
Nonstandard Device 2 2
Product Quality Problem 2 2
Compatibility Problem 2 2
Positioning Problem 1 1
Failure to Form Staple 1 1
Activation, Positioning or Separation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Shipping Damage or Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Detachment of Device or Device Component 1 1
Patient-Device Incompatibility 1 1
Mechanical Problem 1 1
Appropriate Term/Code Not Available 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Hematoma 4 4
Visual Impairment 3 3
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 2 2
No Known Impact Or Consequence To Patient 2 2
Unspecified Infection 2 2
Inflammation 2 2
Skin Inflammation/ Irritation 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Impaired Healing 1 1
Swelling 1 1
No Consequences Or Impact To Patient 1 1
Wound Dehiscence 1 1
Erosion 1 1
Fall 1 1
Granuloma 1 1
Hyperplasia 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Nodule 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Aug-06-2021
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