FDA Adverse Event
Malfunction
Summary report: N
VERTEBRAL BODY STENT ACCESS KIT
MDR report key: 2823703
·
Received October 10, 2012
Report
- Report Number
- 2520274-2012-02230
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Report Date
- September 11, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- NDN
- PMA / PMN Number
- K110604
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THAT THERE WAS NO VOLUME MARKINGS ON THE INFLATION UNIT. THE EXACT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE. PLACEHOLDER.
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT IS ENTERING THE COMPLAINT SYSTEM.
Description of Event or Problem · 1
A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: SCALE FOR A SALINE LIQUID WAS NOT PRINTED ON THE DEVICE. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEBRAL BODY STENT ACCESS KIT | VERTEBRAL BODY STENT ACCESS KIT | NDN | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |