FDA Adverse Event
Malfunction
Summary report: N
PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
MDR report key: 10646363
·
Received October 7, 2020
Report
- Report Number
- 2031049-2020-00084
- Event Type
- Malfunction
- Date Received
- October 7, 2020
- Date of Event
- October 1, 2020
- Report Date
- October 7, 2020
- Manufacturer
- TMJ SOLUTIONS, INC.
- Product Code
- LZD
- UDI-DI
- B004TYYNNNNLF0
- PMA / PMN Number
- P980052
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON REPORTED THAT THIS PATIENT HAD DEVELOPED A SIGNIFICANT AMOUNT OF HETEROTOPIC BONE BETWEEN THE PLANNING AND IMPLANT SURGERY STAGES. THE SURGEON STATED THAT HE REMOVED TOO MUCH BONE, WHICH LEADS TO THE DEVICE NOT BEING PROPERLY SUPPORTED. THE SURGEONS PLAN TO HAVE A NEW FOSSA COMPONENT DESIGNED AND MANUFACTURED.
Description of Event or Problem · 1
THE PATIENT'S LEFT FOSSA COMPONENT WAS REMOVED DUE TO FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1104869 | PATIENT-FITTED TMJ LEFT FOSSA COMPONENT | LEFT FOSSA COMPONENT | LZD | TMJ SOLUTIONS, INC. | TYY-NNNNLF | W51877 | B004TYYNNNNLF0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R |