| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MIS TI CFX FEN POLY 7X45 | BONE CEMENT, POSTERIOR SCREW AUGMENTATION | MEDOS INTERNATIONAL SàRL CH | PML | 186727745 | 186727745 | 131106 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-15 | 0 | 1. R |
Patient 1
(B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient 1
IT WAS REPORTED: BROKEN ROD AT L5 LEFT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). LOOSE PEDICLE SCREW L5 RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). BROKEN PEDICLE SCREW S1 RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). BROKEN ILIAC SCREW RIGHT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). LOOSE PEDICLE SCREW L5 LEFT / CAUSED THE REVISION (REVISION CASE TOOK PLACE (B)(6) 2018). BROKEN EXPEDIUM POLYAXIAL SCREWDRIVER / OCCURRED DURING THE REVISION SURGERY (B)(6) 2018. BROKEN POWER EXPEDIUM / OCCURRED DURING THE REVISION SURGERY (B)(6) 2018.