| Device Type ID | 3666 |
| Device Name | Dura Substitute |
| Regulation Description | Dura Substitute. |
| 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 | 882.5910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3666 |
| Device | Dura Substitute |
| Product Code | GXQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Dura Substitute. |
| CFR Regulation Number | 882.5910 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CODMAN & SHURTLEFF, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLLAGEN MATRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JOHNSON & JOHNSON PROFESSIONALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RTI SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 87 |
Appropriate Term/Code Not Available | 26 |
Device Operates Differently Than Expected | 11 |
Insufficient Information | 10 |
Fluid Leak | 7 |
Hole In Material | 7 |
Leak / Splash | 6 |
Separation Failure | 5 |
Torn Material | 5 |
Poor Quality Image | 3 |
Degraded | 3 |
Use Of Device Problem | 2 |
Material Disintegration | 2 |
Failure To Adhere Or Bond | 2 |
Product Quality Problem | 2 |
Material Integrity Problem | 2 |
Sticking | 2 |
Device Contamination With Biological Material | 2 |
Material Separation | 2 |
Unsealed Device Packaging | 2 |
Break | 2 |
Shelf Life Exceeded | 2 |
Microbial Contamination Of Device | 1 |
Defective Device | 1 |
Device Expiration Issue | 1 |
Material Rupture | 1 |
Off-Label Use | 1 |
Device Remains Implanted | 1 |
Repair | 1 |
Detachment Of Device Component | 1 |
Y-Piece Connector | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Difficult To Remove | 1 |
Patient-Device Incompatibility | 1 |
Component Missing | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Material Puncture / Hole | 1 |
Seal | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 211 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Oct-11-2018 |