FDA Adverse Event
Malfunction
Summary report: N
INNOVASIS
MDR report key: 2313033
·
Received October 25, 2011
Report
- Report Number
- 2313033
- Event Type
- Malfunction
- Date Received
- October 25, 2011
- Date of Event
- August 23, 2011
- Report Date
- October 25, 2011
- Manufacturer
- INNOVASIS
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
DURING A FOLLOW-UP, POST SURGERY APPOINTMENT, PATIENT EXPLAINED HE WAS HAVING AN INCREASE OF PAIN. X-RAYS SHOWED FAILED IMPLANTS FROM THE IMPLANT SURGERY -- THE SET SCREWS WERE DISLODGED FROM THE PEDICLE SCREWS, EXCEPT THE RIGHT S1 SCREW AND THE RODS HAD COME OUT OF THE PEDICLE SCREW TULIPS. PATIENT HAD A SECOND SURGERY TO REMOVE FAILED IMPLANTS AND PLACE NEW ONES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVASIS | 7.5 X 50 SCREW (2) | HWC | INNOVASIS | * | 1001 | |
| 2 | INNOVASIS | 7.5 X 55 SCREW (2) | HWC | INNOVASIS | * | 0802 | |
| 3 | INNOVASIS | LOCKING CAP POLYAXIAL (4) | JDT | INNOVASIS | * | 1101 | |
| 4 | INNOVASIS | CROSS CONNECTOR 50-60 | MNI | INNOVASIS | * | 1002 | |
| 5 | INNOVASIS | 6MM X 55 MM ROD | JDN | INNOVASIS | * | 0901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | NO OTHER THERAPIES |