FDA Adverse Event
Injury
Summary report: N
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
MDR report key: 8007506
·
Received October 25, 2018
Report
- Report Number
- 2031049-2018-00034
- Event Type
- Injury
- Date Received
- October 25, 2018
- Date of Event
- September 26, 2018
- Report Date
- October 25, 2018
- Manufacturer
- TMJ SOLUTIONS, INC.
- Product Code
- LZD
- UDI-DI
- B004TYYNNNNM0
- PMA / PMN Number
- P980052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PATIENT RECEIVED BILATERAL IMPLANTS IN (B)(6) 2018. THE CONDYLAR COMPONENT WAS REMOVED AND REPOSITIONED TO BE SEATED IN THE MOST POSTERIOR MEDIAL ASPECT OF THE FOSSA. THE SURGEON REPORTED THAT THE PATIENT HAS BEEN FUNCTIONING WELL AND THAT THE DISLOCATION HAS NOT REOCCURRED.
Description of Event or Problem · 1
THE PATIENT'S RIGHT TMJ IMPLANTS BECAME DISLOCATED, AND THE SURGEON REPOSITIONED THE MANDIBULAR COMPONENT IN ORDER TO REDUCE THE DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 845049 | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | TEMPOROMANDIBULAR JOINT IMPLANT | LZD | TMJ SOLUTIONS, INC. | TYY-NNNNM | W45462 | B004TYYNNNNM0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |