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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device holder, head, neurosurgical (skull clamp)
Product CodeHBL
Regulation Number 882.4460
Device Class 2


Premarket Reviews
ManufacturerDecision
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO MED INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 1028 1028
2020 607 607
2021 512 512
2022 268 268
2023 265 265
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 984 984
Mechanical Problem 651 651
Device Slipped 536 536
Mechanics Altered 127 127
Loose or Intermittent Connection 120 120
Break 106 106
Adverse Event Without Identified Device or Use Problem 80 80
Unstable 40 40
Physical Resistance/Sticking 39 39
Use of Device Problem 24 24
Insufficient Information 19 19
Crack 17 17
Device Handling Problem 17 17
Mechanical Jam 15 15
Material Integrity Problem 11 11
Fracture 10 10
Pressure Problem 10 10
Decrease in Pressure 9 9
Naturally Worn 9 9
Detachment of Device or Device Component 7 7
Noise, Audible 6 6
Unintended System Motion 6 6
Material Too Soft/Flexible 5 5
Material Too Rigid or Stiff 4 4
Material Fragmentation 4 4
Difficult to Open or Close 4 4
Device Dislodged or Dislocated 3 3
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Defective Component 3 3
Output Problem 3 3
Defective Device 3 3
Dull, Blunt 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Positioning Problem 3 3
Unclear Information 2 2
Material Separation 2 2
Material Deformation 2 2
Material Discolored 2 2
Compatibility Problem 2 2
Difficult to Remove 2 2
Material Split, Cut or Torn 2 2
Retraction Problem 2 2
Component Missing 2 2
Degraded 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
Unauthorized Access to Computer System 1 1
Connection Problem 1 1
Activation Failure 1 1
Migration or Expulsion of Device 1 1
Failure to Cycle 1 1
Material Disintegration 1 1
Human-Device Interface Problem 1 1
Device Reprocessing Problem 1 1
Improper or Incorrect Procedure or Method 1 1
No Pressure 1 1
Peeled/Delaminated 1 1
Incomplete or Inadequate Connection 1 1
Component or Accessory Incompatibility 1 1
Positioning Failure 1 1
Misassembly by Users 1 1
Disconnection 1 1
Sharp Edges 1 1
Separation Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Calibration Problem 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1052 1052
No Clinical Signs, Symptoms or Conditions 651 651
Laceration(s) 518 518
No Known Impact Or Consequence To Patient 331 331
No Patient Involvement 81 81
Injury 45 45
Insufficient Information 20 20
Skull Fracture 13 13
Hemorrhage/Bleeding 11 11
Unspecified Tissue Injury 11 11
Needle Stick/Puncture 8 8
Skin Tears 7 7
Hematoma 5 5
Bone Fracture(s) 3 3
Bruise/Contusion 2 2
Contusion 2 2
Suture Abrasion 2 2
Hyperextension 2 2
No Information 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Missing Value Reason 1 1
Intervertebral Disc Compression or Protrusion 1 1
Spinal Cord Injury 1 1
Radiation Underdose 1 1
Pain 1 1
Skin Discoloration 1 1
Fall 1 1
Abrasion 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Apr-14-2022
2 Deerfield Imaging, Inc. II Oct-18-2019
3 Integra LifeSciences Corp. II Dec-08-2020
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