FDA Adverse Event
Malfunction
Summary report: N
WIRE
MDR report key: 2488226
·
Received February 24, 2012
Report
- Report Number
- 2520274-2012-00290
- Event Type
- Malfunction
- Date Received
- February 24, 2012
- Report Date
- February 1, 2012
- Manufacturer
- SYNTHES (USA)
- Product Code
- HXS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE 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
AFTER A HEART PROCEDURE THE PATIENT WAS CLOSED WITH (2) WIRES IN THE MANUBRIUM, (3) STERNAL ZIPFIX WITH NEEDLE ON THE STERNUM, AND A WIRE AT THE ZYPHOID. ON A FOLLOW-UP SCAN THE STERNUM HAD "SHIFTED UP". REPORTEDLY THE STERNUM HAS HEALED IN AN IMPROPER POSITION. THE SURGEON HAS NO PLANS TO RE-OPEN THE PATIENT AT THIS TIME. THIS REPORT IS #6 OF 6 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIRE | WIRE | HXS | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |