Definition: Call For PMAs To Be Filed By 3/30/99 Per 63 FR 71746 On 12/30/98 - Indicated For Reconstruction Of The Temporomandibular Joint.
| Device Type ID | 1315 |
| Device Name | Joint, Temporomandibular, Implant |
| Physical State | The Device Is A Ball And Socket Joint With One Side Mounted To The Jaw And The Other Side Mounted To The Head Right In Front Of The Ear. |
| Regulation Description | Total Temporomandibular Joint Prosthesis. |
| 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 | PMA |
| CFR Regulation Number | 872.3940 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LZD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1315 |
| Device | Joint, Temporomandibular, Implant |
| Product Code | LZD |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Total Temporomandibular Joint Prosthesis. |
| CFR Regulation Number | 872.3940 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 192 |
Insufficient Information | 108 |
Migration Or Expulsion Of Device | 37 |
Malposition Of Device | 24 |
Inadequacy Of Device Shape And/or Size | 24 |
Device Dislodged Or Dislocated | 21 |
Patient-Device Incompatibility | 19 |
Noise, Audible | 13 |
Fracture | 12 |
Fitting Problem | 9 |
Migration | 8 |
Appropriate Term/Code Not Available | 6 |
Retraction Problem | 4 |
Biological Environmental Factor | 4 |
Loose Or Intermittent Connection | 4 |
Biocompatibility | 3 |
Device Markings / Labelling Problem | 3 |
Break | 3 |
Incorrect Device Or Component Shipped | 3 |
Installation-Related Problem | 2 |
Difficult To Position | 2 |
Osseointegration Problem | 2 |
Failure To Adhere Or Bond | 1 |
Defective Component | 1 |
Bent | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Incorrect Measurement | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Biofilm Coating In Device | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Nonstandard Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Failure | 1 |
Material Deformation | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 517 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet Microfixation, LLC | II | Dec-16-2014 |
| 2 | Biomet Microfixation, LLC | II | Sep-02-2014 |
| 3 | TMJ Solutions Inc | II | Apr-19-2018 |