FDA Adverse Event
Injury
Summary report: N
LOCKING CONDYLAR DISTAL FEMUR PLATE
MDR report key: 1900166
·
Received November 10, 2010
Report
- Report Number
- 1719045-2010-00326
- Event Type
- Injury
- Date Received
- November 10, 2010
- Report Date
- October 11, 2010
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HRS
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OF LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PT IMPLANTED WITH A LOCKING CONDYLAR DISTAL FEMUR PLATE ON AN UNK DATE FOR A SUPRA CONDYLAR FEMUR FRACTURE. AFTER APPROXIMATELY EIGHT MONTHS TO ONE YEAR, THE PLATE BROKE POSTOPERATIVELY. A NON-UNION WAS NOTED. X-RAYS WERE TAKEN PRIOR TO PROCEDURE. PLATE WAS REMOVED AND PT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING CONDYLAR DISTAL FEMUR PLATE | LOCKING CONDYLAR DISTAL FEMUR PLATE | HRS | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREWS |