| Device Type ID | 5928 |
| Device Name | Implant, Dermal, For Aesthetic Use |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LMH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5928 |
| Device | Implant, Dermal, For Aesthetic Use |
| Product Code | LMH |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3824 |
Detachment Of Device Or Device Component | 434 |
Detachment Of Device Component | 376 |
Gel Leak | 302 |
Expulsion | 237 |
Crack | 201 |
Break | 195 |
Leak / Splash | 195 |
Improper Or Incorrect Procedure Or Method | 186 |
Migration Or Expulsion Of Device | 107 |
Burst Container Or Vessel | 73 |
Difficult Or Delayed Positioning | 48 |
Difficult Or Delayed Activation | 40 |
Defective Component | 27 |
Use Of Device Problem | 24 |
Migration | 18 |
Insufficient Information | 18 |
Off-Label Use | 18 |
Coagulation In Device Or Device Ingredient | 13 |
Device Contamination With Chemical Or Other Material | 11 |
Shelf Life Exceeded | 11 |
Clumping In Device Or Device Ingredient | 7 |
Fracture | 7 |
Patient-Device Incompatibility | 7 |
Difficult To Remove | 6 |
Occlusion Within Device | 6 |
No Apparent Adverse Event | 6 |
Loose Or Intermittent Connection | 6 |
Fitting Problem | 5 |
Bent | 5 |
Device Operates Differently Than Expected | 4 |
Infusion Or Flow Problem | 4 |
Material Integrity Problem | 3 |
Activation, Positioning Or Separation Problem | 3 |
Device Dislodged Or Dislocated | 3 |
Material Deformation | 3 |
Partial Blockage | 3 |
Contamination Of Device Ingredient Or Reagent | 3 |
Material Too Rigid Or Stiff | 3 |
Material Rupture | 3 |
Short Fill | 2 |
Device Markings / Labelling Problem | 2 |
Defective Device | 2 |
Improper Flow Or Infusion | 2 |
Packaging Problem | 2 |
Mechanical Jam | 2 |
Positioning Failure | 2 |
Material Opacification | 2 |
Unsealed Device Packaging | 2 |
Component Missing | 2 |
Unintended Ejection | 2 |
Particulates | 2 |
Connection Problem | 2 |
Biofilm Coating In Device | 2 |
Device Ingredient Or Reagent Problem | 2 |
Material Twisted / Bent | 2 |
Physical Resistance | 2 |
Operating System Becomes Nonfunctional | 1 |
Product Quality Problem | 1 |
Backflow | 1 |
Delivered As Unsterile Product | 1 |
Explosion | 1 |
Retraction Problem | 1 |
Degraded | 1 |
Disassembly | 1 |
Overcorrection | 1 |
Appropriate Term/Code Not Available | 1 |
Device Handling Problem | 1 |
Material Separation | 1 |
Incomplete Or Missing Packaging | 1 |
Complete Blockage | 1 |
Pressure Problem | 1 |
Chemical Spillage | 1 |
Delivery System Failure | 1 |
Noise, Audible | 1 |
Positioning Problem | 1 |
Malposition Of Device | 1 |
Fungus In Device Environment | 1 |
Dull, Blunt | 1 |
Disconnection | 1 |
| Total Device Problems | 6502 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Enhancement Medical, LLC | I | Aug-08-2014 |
| 2 | Merz North America, Inc. | II | Aug-19-2016 |
| 3 | Merz North America, Inc. | II | Dec-03-2015 |
| 4 | Orthovita, Inc., DBA Stryker Orthobiologics. | II | Mar-30-2015 |