FDA Adverse Event
Injury
Summary report: N
95 GED DCS PLATE
MDR report key: 1352280
·
Received March 27, 2009
Report
- Report Number
- 1719045-2009-00049
- Event Type
- Injury
- Date Received
- March 27, 2009
- Report Date
- March 2, 2009
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HRS
- PMA / PMN Number
- K840954
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION HAS NOT BEEN CONCLUDED, NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS SPECIFIC LOT NUMBER HAS BEEN REQUESTED.
Description of Event or Problem · 1
SURGEON ADVISED A 20 HOLE DCS PLATE BROKE POST OPERATIVE AND WAS REMOVED. PLATE WAS IMPLANTED DURING REVISION OF A FRACTURE EITHER ABOVE A PLATE OR WHERE A PLATE HAD BEEN. THE PATIENT HAS AN IPSOLATERAL TOTAL KNEE AND HIP. THE PLATE WAS PLACED AND SECURED WITH SCREWS AND TWO CABLES WITH VERY GOOD REDUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 95 GED DCS PLATE | DHS/DCS PLATES | HRS | SYNTHES MONUMENT | NA | 1013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | CABLES| SCREWS |