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TPLC
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show TPLC since
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2024
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Device
holder, head, neurosurgical (skull clamp)
Product Code
HBL
Regulation Number
882.4460
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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