| Device Type ID | 3708 |
| Device Name | Holder, Head, Neurosurgical (skull Clamp) |
| Regulation Description | Neurosurgical Head Holder (skull Clamp). |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4460 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3708 |
| Device | Holder, Head, Neurosurgical (skull Clamp) |
| Product Code | HBL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neurosurgical Head Holder (skull Clamp). |
| CFR Regulation Number | 882.4460 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEERFIELD IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Slipped | 152 |
Device Operates Differently Than Expected | 100 |
Unintended Movement | 83 |
Insufficient Information | 53 |
No Apparent Adverse Event | 51 |
Mechanical Problem | 50 |
Loose Or Intermittent Connection | 43 |
Use Of Device Problem | 42 |
Device Handling Problem | 35 |
Break | 31 |
Defective Device | 27 |
Adverse Event Without Identified Device Or Use Problem | 20 |
Material Disintegration | 13 |
Positioning Problem | 13 |
Difficult Or Delayed Positioning | 12 |
Material Integrity Problem | 10 |
Unstable | 9 |
Clamp | 9 |
Appropriate Term/Code Not Available | 7 |
Unintended System Motion | 6 |
Crack | 6 |
Unintended Head Motion | 6 |
Detachment Of Device Or Device Component | 5 |
Device Dislodged Or Dislocated | 5 |
Product Quality Problem | 5 |
Fracture | 4 |
Component Missing | 4 |
Mechanics Altered | 4 |
Difficult To Position | 3 |
Material Separation | 3 |
Detachment Of Device Component | 3 |
Decrease In Pressure | 3 |
Screw | 3 |
Disassembly | 3 |
Device Operational Issue | 3 |
Lock | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Defective Component | 3 |
Pin | 2 |
Failure To Adhere Or Bond | 2 |
Failure To Service | 2 |
Bent | 2 |
Device Difficult To Setup Or Prepare | 2 |
Metal Shedding Debris | 2 |
Sticking | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Material Deformation | 2 |
Knob | 2 |
Device Issue | 2 |
Material Too Rigid Or Stiff | 2 |
Locking Mechanism | 2 |
Disconnection | 2 |
Difficult Or Delayed Activation | 1 |
Hinge | 1 |
Component Falling | 1 |
Premature Activation | 1 |
Torn Material | 1 |
Failure To Align | 1 |
Noise, Audible | 1 |
Adapter (Adaptor) | 1 |
Separation Failure | 1 |
Device Packaging Compromised | 1 |
Material Protrusion / Extrusion | 1 |
Material Torqued | 1 |
Spring | 1 |
Positioning Failure | 1 |
Material Fragmentation | 1 |
Device Maintenance Issue | 1 |
No Pressure | 1 |
Pressure Problem | 1 |
Difficult To Open Or Close | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Output Above Specifications | 1 |
Device Displays Incorrect Message | 1 |
Connection Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Failure To Fold | 1 |
Device Stops Intermittently | 1 |
| Total Device Problems | 891 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Deerfield Imaging | II | Sep-22-2017 |
| 2 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 3 | Pro-Med Instruments Gmbh | I | Sep-17-2018 |
| 4 | Pro-Med Instruments Gmbh | II | Dec-05-2017 |