FDA Adverse Event
Other
Summary report: N
STERNAL CABLE SYSTEM
MDR report key: 998328
·
Received June 9, 2007
Report
- Report Number
- 1833824-2007-00004
- Event Type
- Other
- Date Received
- June 9, 2007
- Date of Event
- February 1, 2006
- Report Date
- June 8, 2007
- Manufacturer
- PIONEER LABORATORIES
- Product Code
- GAQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION CONTINUES. F/U WITH THE USER OF THIS DEVICE HAS YET TO YIELD ANY FURTHER INFO TO HELP IN THIS INVESTIGATION. DEVICES THAT WERE ALSO REPORTED WITH MDR FILED BY THE PHYSICIAN ARE AS FOLLOWS: PART# 400-727, LOT# 314540, MFG DATE: 05/2006, EXP DATE: 05/2011. PART# 401-096, LOT# 307342, MFG DATE: 7/1/04, EXP DATE: 06/2009.
Description of Event or Problem · 1
DR REPORTED THAT HE "OBSERVED AN INCREASE IN WOUND INFECTIONS AND AN INCREASE IN STERNAL DEHISCENCE" WHICH HE BELIEVED MAY BE PROD RELATED. "IN ONE PT ONE OF THE CABLES FRACTURED AND PULLED THROUGH THE BONE OF THE STERNAL CLOSURE CAUSING STERNAL INSTABILITY AND SUBSEQUENT INFECTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERNAL CABLE SYSTEM | STERNAL CABLE | GAQ | PIONEER LABORATORIES | 400-689 | 314527 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other| R |