FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 926590
·
Received March 28, 2007
Report
- Report Number
- 2242816-2007-00014
- Event Type
- Malfunction
- Date Received
- March 28, 2007
- Date of Event
- January 16, 2007
- Report Date
- March 16, 2007
- Manufacturer
- EBI
- Product Code
- KWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PARTS WERE USED: CATALOG #6451, LOT #51139, CATALOG #6451, LOT #51155, CATALOG #6451, LOT #935530.
Description of Event or Problem · 1
WHEN A PLUG WAS INSERTED, THE SIDE OF THE REDUCTION SEAT DEFORMED AND BROKE OFF. A PLUG COULD NOT BE INSERTED AND THE PATIENT WAS WITHOUT THE PLUGS OF SOME SCREWS. NO PROBLEMS WERE REPORTED WITH THE SHORT SEATS OR FIXED SCREWS. PATIENT OUTCOME: NO COMPLICATIONS TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | KWP | KWP | EBI | 6453 | 920360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |