FDA Adverse Event
Injury
Summary report: N
VALEO C
MDR report key: 2116440
·
Received June 1, 2011
Report
- Report Number
- 3005032068-2011-00001
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- October 8, 2009
- Report Date
- May 27, 2011
- Manufacturer
- AMEDICA CORP.
- Product Code
- MQP
- PMA / PMN Number
- K073505
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT # 900098. EVENT REPORTED BY REQUEST OF FDA. CAUSE OF INFECTION UNK. DEVICE EXPLANTED BY PT REQUEST.
Description of Event or Problem · 1
THREE VALEO C SPACERS WERE REVISED AND REMOVED DUE TO AN INFECTION. PT RECEIVED A CORPECTOMY DURING THE REVISION SURGERY AND IS REPORTED TO BE FINE. NOT KNOWN WHAT CAUSED INFECTION. THERE WAS INFLAMMATION AND SWELLING A FEW WEEKS POST-OP AND SURGEON WAS OBSERVING PT AND HAD HER ON ANTIBIOTICS. SURGEON REPORTED PT WANTED TO DO REVISION RATHER THAN CONTINUE ANTIBIOTICS. DURING REVISION, SURGEON REPORTED 3 SPACERS WERE VERY DIFFICULT TO REMOVE; GRAFT HOLES CONTAINED HEALTHY BONE AND OUTSIDE OF THE IMPLANT SHOWED "SOME SIGNS" OF BONE ATTACHMENT. CERVICAL PLATE USED DURING ORIGINAL SURGERY: K2M.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VALEO C | VERTEBRAL BODY REPLACEMENT | MQP | AMEDICA CORP. | 900058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | MANUFACTURER: K2M.| CERVICAL PLATE ALSO USED DURING ORIGINAL SURGERY, |