FDA Adverse Event
Other
Summary report: N
MAGNUM X KNOTLESS IMPLANT
MDR report key: 2222540
·
Received August 11, 2011
Report
- Report Number
- 2032380-2011-00065
- Event Type
- Other
- Date Received
- August 11, 2011
- Date of Event
- June 24, 2011
- Report Date
- August 11, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- MBI
- PMA / PMN Number
- K081497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PT'S AGE AND GENDER WERE REQUESTED, BUT HAVE NOT BEEN PROVIDED. THE TWO DEVICES WERE REPORTED AS RETURNING FOR INVESTIGATION. TO DATE, THE DEVICES HAVE NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETED. THE ADDITIONAL DEVICE USED IN THE SAME PROCEDURE WAS FILED UNDER MDR 2032380-2011-00064. REF: ARTHROCARE RMA (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO ARTHROCARE THAT A PT UNDERWENT A PROCEDURE USING TWO MAGNUM X KNOTLESS IMPLANTS. THE IMPLANT WIRE REPORTEDLY BROKE, CAUSING A SURGICAL DELAY OF TWO HOURS. THE SURGEON WAS ABLE TO COMPLETE THE REPAIR WITH NO NEED FOR ADDITIONAL INCISIONS, NO PT ADVERSE EFFECT OR PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAGNUM X KNOTLESS IMPLANT | FASTENER, FIXATION, NONDEGRADABLE, SOFT | MBI | ARTHROCARE CORP. | 1002368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |