FDA Adverse Event
Malfunction
Summary report: N
BASIC ORBITAL FLOOR PLATE, MEDIUM,STERILE, 0.3MM
MDR report key: 3953604
·
Received July 23, 2014
Report
- Report Number
- 0008010177-2014-00188
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 27, 2014
- Report Date
- July 3, 2014
- Manufacturer
- STRYKER LEIBINGER FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVALUATION AS THE PATIENT RETAINED THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE RETAINED BY PATIENT.
Description of Event or Problem · 1
AN ORBITAL PLATE WAS USED IN SURGERY FOR AN ORBITAL FLOOR FRACTURE. BEFORE THE SURGERY, THE PLATE WAS CUT IN HALF LONGITUDINALLY BECAUSE IT WAS TOO WIDE FOR THE PATIENT. AFTER THE SURGERY, THE PATIENT PRESENTED WITH EYE PAIN AND THE PLATE AND SCREWS WERE EXTRACTED ON THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430344 | BASIC ORBITAL FLOOR PLATE, MEDIUM,STERILE, 0.3MM | IMPLANT | JEY | STRYKER LEIBINGER FREIBURG | M4T01FAV06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |