TI PANGEA LOCKING CAP
Report
- Report Number
- 2530088-2012-00405
- Event Type
- Injury
- Date Received
- July 6, 2012
- Report Date
- June 8, 2012
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- NKB
- PMA / PMN Number
- K082572
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
CAT# AND LOT#: THE PART NUMBERS AND LOT NUMBERS OF THE ENTIRE CONSTRUCT WERE PROVIDED. SYNTHES IS UNABLE TO DETERMINE WHICH OF THE 6 LOCKING CAPS AND THE CORRESPONDING LOT NUMBERS WERE IMPLANTED IN THE REPORTED VERTEBRAL BODIES OF L5 AND S1, THEREFORE, ALL CAT #S OF THE LOCKING CAPS AND THE CORRESPONDING LOT#S ARE BEING REPORTED AS FOLLOWS: CAT # 04.620.000; LOT #S 6832969 X 3, 6100163, 6817944, 6895662. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.
PT WAS IMPLANTED WITH PANGEA CONSTRUCT FROM L4-S1 ON (B)(6) 2012. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PT HAD INCREASED LOW BACK PAIN. X-RAYS DEMONSTRATED THE RODS ON BOTH SIDES WERE DISLODGED AND LEFT L5 SCREW HEAD POPPED OFF. THE LEFT ROD OF THE CONSTRUCT TWISTED. THE SCREW AT LEFT L5 WAS STILL ATTACHED IN THE BONE. THE HEAD OF THE SCREW AT LEFT L5 POPPED OUT BUT WAS STILL ATTACHED TO THE ROD. THE ROD AT RIGHT S1 MIGRATED SUPERIORLY AND WAS PARTIALLY ENGAGED IN THE RIGHT S1 PEDICLE SCREW. SURGEON REMOVED ALL HARDWARE AND PT WAS REVISED TO MATRIX CONSTRUCT. THIS IS THE 5TH OF 5 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI PANGEA LOCKING CAP | PANGEA LOCKING CAP | NKB | SYNTHES BRANDYWINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention | LOCKING CAPS| RODS| SCREWS| SCREWS| LOCKING CAPS| RODS |