FDA Adverse Event
Injury
Summary report: N
2520274-2013-04115
MDR report key: 3212878
·
Received July 9, 2013
Report
- Report Number
- 2520274-2013-04115
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 11, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- JEY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
A MATRIX MANDIBLE 2.5MM LEFT ANGLE RECONSTRUCTION PLATE ERODED THROUGH THE PATIENTS SKIN AFTER RADIATION TREATMENT, FOLLOWING SURGERY FOR MALIGNANT NEOPLASM OF MANDIBLE. THE PLATE WAS REMOVED (B)(6) 2013. THE MANDIBLE/FIBULA GRAFT HEALED AND PATIENT IS DOING WELL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR AN UNKNOWN MATRIX MANDIBLE 2.5MM LEFT ANGLE RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313490 | JEY | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |