• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device holder, head, neurosurgical (skull clamp)
Regulation Description Neurosurgical head holder (skull clamp).
Product CodeHBL
Regulation Number 882.4460
Device Class 2


Premarket Reviews
ManufacturerDecision
PRO MED INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2020 607 607
2021 512 512
2022 268 268
2023 265 265
2024 197 197
2025 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 567 567
Mechanical Problem 495 495
Unintended Movement 355 355
Mechanics Altered 131 131
Unstable 109 109
Loose or Intermittent Connection 92 92
Adverse Event Without Identified Device or Use Problem 82 82
Break 58 58
Physical Resistance/Sticking 29 29
Insufficient Information 16 16
Pressure Problem 9 9
Mechanical Jam 9 9
Fracture 7 7
Decrease in Pressure 7 7
Use of Device Problem 7 7
Unintended System Motion 6 6
Naturally Worn 5 5
Material Integrity Problem 5 5
Device Dislodged or Dislocated 5 5
Material Fragmentation 4 4
Difficult to Open or Close 4 4
Noise, Audible 3 3
Appropriate Term/Code Not Available 3 3
No Apparent Adverse Event 3 3
Output Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Dull, Blunt 3 3
Defective Component 3 3
Material Too Rigid or Stiff 3 3
Component Missing 2 2
Difficult to Remove 2 2
Retraction Problem 2 2
Material Discolored 2 2
Material Split, Cut or Torn 2 2
Unclear Information 2 2
Improper or Incorrect Procedure or Method 1 1
Migration or Expulsion of Device 1 1
Material Separation 1 1
Peeled/Delaminated 1 1
Increase in Pressure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Detachment of Device or Device Component 1 1
Connection Problem 1 1
Component or Accessory Incompatibility 1 1
Calibration Problem 1 1
Malposition of Device 1 1
Defective Device 1 1
No Pressure 1 1
Failure to Align 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 750 750
Laceration(s) 545 545
No Known Impact Or Consequence To Patient 309 309
No Consequences Or Impact To Patient 201 201
Insufficient Information 43 43
No Patient Involvement 43 43
Unspecified Tissue Injury 22 22
Injury 15 15
Skull Fracture 13 13
Hemorrhage/Bleeding 11 11
Needle Stick/Puncture 9 9
Skin Tears 7 7
Abrasion 7 7
Hematoma 7 7
Bone Fracture(s) 3 3
Suture Abrasion 2 2
Hyperextension 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bruise/Contusion 2 2
No Code Available 2 2
Irritation 1 1
Pain 1 1
Paresis 1 1
Skin Discoloration 1 1
Brain Injury 1 1
Spinal Cord Injury 1 1
Intervertebral Disc Compression or Protrusion 1 1
Skin Disorders 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Ecchymosis 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
No Information 1 1
Cerebral Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Apr-14-2022
2 Integra LifeSciences Corp. II Dec-08-2020
3 Pro-Med Instruments Gmbh II May-28-2025
-
-