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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

MDR Year MDR Reports MDR Events
2021 28 28
2022 13 15
2023 11 12
2024 3 5
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 16
Adverse Event Without Identified Device or Use Problem 11 11
Device Appears to Trigger Rejection 6 6
Difficult to Open or Close 6 7
Insufficient Information 5 6
Unintended Movement 4 6
Patient Device Interaction Problem 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Unstable 3 3
Human-Device Interface Problem 3 3
Mechanics Altered 2 2
Product Quality Problem 2 2
Nonstandard Device 2 2
Mechanical Problem 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Failure to Form Staple 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 51
Failure of Implant 4 4
Hematoma 4 4
Insufficient Information 4 4
Skin Inflammation/ Irritation 3 3
Inflammation 2 2
Hypersensitivity/Allergic reaction 1 1
Hyperplasia 1 1
Post Operative Wound Infection 1 1
Fall 1 1
Swelling/ Edema 1 1
Nodule 1 1
Granuloma 1 1

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