FDA Adverse Event
Injury
Summary report: N
CORNERSTONE-SR CAGE SYSTEM
MDR report key: 3180840
·
Received June 20, 2013
Report
- Report Number
- 1030489-2013-02444
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- ODP
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
A PATIENT REPORTEDLY UNDERWENT A CERVICAL PROCEDURE AT UNKNOWN LEVELS. POST-OPERATIVE CAGE BACK OUT WAS REPORTED, AND A REVISION SURGERY IS SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280401 | CORNERSTONE-SR CAGE SYSTEM | ODP | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |