| Device Type ID | 1326 |
| Device Name | External Mandibular Fixator And/or Distractor |
| Regulation Description | Bone Plate. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.4760 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1326 |
| Device | External Mandibular Fixator And/or Distractor |
| Product Code | MQN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Plate. |
| CFR Regulation Number | 872.4760 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KLS MARTIN GMBH And CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SYNTHES USA PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 94 |
Adverse Event Without Identified Device Or Use Problem | 68 |
Device Operates Differently Than Expected | 28 |
Fracture | 18 |
Osseointegration Problem | 11 |
Mechanical Jam | 8 |
Migration Or Expulsion Of Device | 7 |
Device Dislodged Or Dislocated | 6 |
Unintended Movement | 6 |
Detachment Of Device Or Device Component | 6 |
Detachment Of Device Component | 5 |
Failure To Adhere Or Bond | 5 |
Material Fragmentation | 4 |
Mechanical Problem | 4 |
Loose Or Intermittent Connection | 3 |
Difficult To Advance | 3 |
Bent | 3 |
Screw | 3 |
Failure To Osseointegrate | 2 |
Device Inoperable | 2 |
Device-Device Incompatibility | 2 |
Fitting Problem | 1 |
Human Factors Issue | 1 |
Positioning Problem | 1 |
Device Damaged Prior To Use | 1 |
Entrapment Of Device | 1 |
Device Slipped | 1 |
Naturally Worn | 1 |
Separation Problem | 1 |
Difficult To Remove | 1 |
Heads | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Use Of Device Problem | 1 |
Difficult To Open Or Close | 1 |
Appropriate Term/Code Not Available | 1 |
Weld | 1 |
| Total Device Problems | 303 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Aug-17-2016 |
| 2 | Synthes, Inc. | II | Jan-23-2015 |
| 3 | Synthes, Inc. | I | Aug-20-2014 |