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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
Device Handling Problem 17 17
Crack 17 17
Mechanical Jam 15 15
Material Integrity Problem 11 11
Pressure Problem 10 10
Fracture 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
Difficult to Open or Close 4 4
Material Fragmentation 4 4
Material Too Rigid or Stiff 4 4
Defective Component 3 3
Dull, Blunt 3 3
Defective Device 3 3
Device Dislodged or Dislocated 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Output Problem 3 3
Positioning Problem 3 3
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 2 2
Material Deformation 2 2
Compatibility Problem 2 2
Component Missing 2 2
Material Separation 2 2
Retraction Problem 2 2
Difficult to Remove 2 2
Material Discolored 2 2
Unclear Information 2 2
Disconnection 1 1
Material Disintegration 1 1
Device Reprocessing Problem 1 1
Failure to Cycle 1 1
Degraded 1 1
Positioning Failure 1 1
Migration or Expulsion of Device 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Calibration Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Human-Device Interface Problem 1 1
Unauthorized Access to Computer System 1 1
No Pressure 1 1
Ejection Problem 1 1
Sharp Edges 1 1
Incomplete or Inadequate Connection 1 1
Separation Problem 1 1
Activation Failure 1 1
Misassembly by Users 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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