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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
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
2019 28 28
2020 16 16
2021 28 28
2022 13 13
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 27 27
Break 13 13
Difficult to Open or Close 10 10
Unstable 9 9
Device Appears to Trigger Rejection 7 7
Insufficient Information 7 7
Unintended Movement 4 4
Patient Device Interaction Problem 4 4
Human-Device Interface Problem 4 4
Appropriate Term/Code Not Available 3 3
Detachment of Device or Device Component 2 2
Compatibility Problem 2 2
Mechanics Altered 2 2
Fracture 2 2
Nonstandard Device 2 2
Product Quality Problem 2 2
Mechanical Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Failure to Form Staple 1 1
Patient-Device Incompatibility 1 1
Activation, Positioning or Separation Problem 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 19 19
Unspecified Infection 7 7
Post Operative Wound Infection 6 6
Hematoma 4 4
Visual Impairment 3 3
Discomfort 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 2 2
Skin Inflammation/ Irritation 2 2
Inflammation 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Swelling 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Wound Dehiscence 1 1
Erosion 1 1
Fall 1 1
Granuloma 1 1
Nodule 1 1
Impaired Healing 1 1
No Consequences Or Impact To Patient 1 1

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