FDA Adverse Event
Injury
Summary report: N
4.5MM LCP PROXIMAL FEMUR
MDR report key: 1163098
·
Received September 16, 2008
Report
- Report Number
- 2520274-2008-00070
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 20, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- PMA / PMN Number
- K030858
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFO WAS NOT PROVIDED DURING THE INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE THE MFR OR THE MFR DATE WITHOUT A LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PT COMPLAINED OF PAIN THREE MOS AFTER AN IMPLANTATION OF A LCP PLATE. A POST-OP X-RAY SHOWED A NON-UNION AND A BROKEN PLATE. SURGEON REVISED THE SHORTER PROXIMAL FEMORAL PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM LCP PROXIMAL FEMUR | PROXIMAL FEMUR PLATE | HRS | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOCKING SCREWS |