FDA Adverse Event
Injury
Summary report: N
TMJ BILATERAL IMPLANTS
MDR report key: 17603524
·
Received August 23, 2023
Report
- Report Number
- 0002031049-2023-00068
- Event Type
- Injury
- Date Received
- August 23, 2023
- Date of Event
- August 8, 2023
- Report Date
- November 28, 2023
- Manufacturer
- TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
- Product Code
- LZD
- UDI-DI
- 07613327626575
- PMA / PMN Number
- P980052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED EVENT COULD BE CONFIRMED AS THE SURGEON PROVIDED THE CURRENT PATIENT¿S CT SCAN THAT SHOWED THE PATIENT¿S MALOCCLUSION. BASED ON THE INVESTIGATION THERE IS NO INDICATION OF AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUES.
Additional Manufacturer Narrative · 0
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
IT WAS REPORTED THERE WILL BE A REVISION SURGERY TO REVISE THE MANDIBULAR COMPONENTS DUE TO PATIENT CONDITION.
Description of Event or Problem · 0
IT WAS REPORTED THERE WILL BE A REVISION SURGERY TO REVISE THE MANDIBULAR COMPONENTS DUE TO PATIENT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1405599 | TMJ BILATERAL IMPLANTS | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | LZD | TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS | T11-552 | 07613327626575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |