FDA Adverse Event
Injury
Summary report: N
WIRES
MDR report key: 2490912
·
Received March 9, 2012
Report
- Report Number
- 2520274-2012-00394
- Event Type
- Injury
- Date Received
- March 9, 2012
- Report Date
- January 30, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- GAQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
PT WAS IMPLANTED WITH 3 STERNAL PLATES, 1 MANUBRIUM PLATE AND 2 STERNAL WIRES ON (B)(6) 2011 FOLLOWING A CABG PROCEDURE. POST IMPLANT, PT WAS NOTED TO HAVE A SEPARATION OF THE MANUBRIUM PLATE (PIN BACKING OUT). THE MANUBRIUM PLATE REMAINED ATTACHED TO THE BONE, BUT THE THREE STERNAL PLATES PULLED OUT ON ONE SIDE AND THE WIRES BEGAN TO PULL THROUGH AND BECAME LOOSE. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. NO NEW HARDWARE WAS PLACED AND PT WAS CLOSED WITH A MUSCLE FLAP. THIS REPORT IS #5 OF 6 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIRES | WIRES | GAQ | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |