FDA Adverse Event
Malfunction
Summary report: N
CORTOSS 10CC OUS
MDR report key: 3870027
·
Received June 12, 2014
Report
- Report Number
- 0002530131-2014-00009
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 8, 2014
- Report Date
- May 28, 2014
- Manufacturer
- STRYKER ORTHOBIOLOGICS-MALVERN
- Product Code
- NDN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT USED AND DISCARDED, LOT INFORMATION NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT LEAKAGE OF CORTOSS WAS OBSERVED DURING POST-OPERATIVE IMAGING OF A PATIENT UNDERGOING A T11 FIXATION WITH SCREW AUGMENTATION. IT SHOULD BE NOTED THAT THIS EVENT OCCURRED IN THE (B)(6) AND WAS USED FOR AN INDICATION (SCREW AUGMENTATION) WHICH IS NOT CLEARED FOR IN THE UNITED STATES. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348232 | CORTOSS 10CC OUS | CORTOSS | NDN | STRYKER ORTHOBIOLOGICS-MALVERN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |