FDA Adverse Event
Injury
Summary report: N
4.5MM LCP PROXIMAL FEMUR PLATE 2 HOLES/139MM-LEFT
MDR report key: 1901680
·
Received November 12, 2010
Report
- Report Number
- 3003506883-2010-00060
- Event Type
- Injury
- Date Received
- November 12, 2010
- Report Date
- October 14, 2010
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HRS
- PMA / PMN Number
- K030858
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; 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 AN LCP PROXIMAL FEMUR PLATE FOR A BASILAR NECK FRACTURE. PT COMPLAINED OF INCREASED PAIN OF LEFT HIP AND F/U X-RAYS TAKEN (B)(6) 2010 SHOWED A BROKEN PLATE. PLATE WAS REMOVED AND PT WAS CONVERTED TO A TOTAL HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5MM LCP PROXIMAL FEMUR PLATE 2 HOLES/139MM-LEFT | LCP PROXIMAL FEMUR PLATE | HRS | SYNTHES ELMIRA | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | SCREWS |