FDA Adverse Event
Other
Summary report: N
LABRALOCK P KNOTLESS FIXATION DEVICE
MDR report key: 1914488
·
Received November 23, 2010
Report
- Report Number
- 2032380-2010-00028
- Event Type
- Other
- Date Received
- November 23, 2010
- Date of Event
- October 8, 2010
- Report Date
- November 23, 2010
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- MBI
- PMA / PMN Number
- K061349
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS AND A F/U REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED. A SECOND DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2032380-2010-00029. (B)(4).
Description of Event or Problem · 1
THE PT UNDERWENT A LABRUM REFIXATION OF THE LEFT SHOULDER USING TWO LABRALOCK P KNOTLESS FIXATION DEVICES. BOTH FIXATION DEVICES FAILED TO LOCK AND WERE REPORTEDLY INSERTED AT THE INCORRECT INCIDENCE ANGLES AND WERE REMOVED IN THE SAME PROCEDURE. IT WAS NOT POSSIBLE TO IMPLANT THESE TWO ANCHORS. THE SURGEON ELECTED TO MOVE TO AN OPEN PROCEDURE TO COMPLETE THE PROCEDURE WITH AN ARTHROCARE MINIMAGNUM IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LABRALOCK P KNOTLESS FIXATION DEVICE | LABRALOCK P KNOTLESS FIXATION DEVICE | MBI | ARTHROCARE CORP. | 1005921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |