FDA Adverse Event
Injury
Summary report: N
TMJ BILATERAL IMPLANTS
MDR report key: 16253797
·
Received January 27, 2023
Report
- Report Number
- 0002031049-2023-00003
- Event Type
- Injury
- Date Received
- January 27, 2023
- Date of Event
- January 11, 2023
- Report Date
- March 30, 2023
- Manufacturer
- TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
- Product Code
- LZD
- PMA / PMN Number
- P980052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED EVENT COULD BE CONFIRMED AS THE SURGEON PROVIDED THE PATIENT¿S CT SCAN. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL, OR MANUFACTURING-RELATED ISSUES. H3 OTHER TEXT: NOT AVAILABLE FOR RETURN.
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICES WERE REMOVED DUE TO HETEROTOPIC BONE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICES WERE REMOVED DUE TO HETEROTOPIC BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412549 | TMJ BILATERAL IMPLANTS | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | LZD | TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS | T11-469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |