FDA Adverse Event
Injury
Summary report: N
INION CPS BIOABSORBABLE FIXATION
MDR report key: 510252
·
Received January 28, 2004
Report
- Report Number
- 9710629-2004-00001
- Event Type
- Injury
- Date Received
- January 28, 2004
- Date of Event
- January 1, 2004
- Report Date
- January 27, 2004
- Manufacturer
- INION LTD.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
TEMPORO MANDIBULAR JOINT ANKYLOSIS SEVERAL WEEKS AFTER BIMAXILLARY TREATMENT OF A MALFORMATION. (LC FORT I AND B550.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INION CPS BIOABSORBABLE FIXATION | BONE FIXATION FASTENER | HWC | INION LTD. | SCR-1208 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R |