FDA Adverse Event
Injury
Summary report: N
4.5MM LCP PROXIMAL TIBIA PLATE4 HOLES/82MM-LEFT
MDR report key: 2924440
·
Received January 22, 2013
Report
- Report Number
- 3003506883-2013-00037
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 28, 2012
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HRS
- PMA / PMN Number
- K011978
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTED DATE OF IMPLANT WAS (B)(6) 2011. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH 4.5MM LCP PROXIMAL TIBIA PLATE AND SCREWS FOR A LEFT PROXIMAL TIBIA FRACTURE IN JUNE 2011. PATIENT WAS RETURNED TO THE O.R ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PATIENT COMPLAINED OF PAINFUL HARDWARE. PATIENTS FRACTURE WAS HEALED. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS. THIS IS 1 OF 6 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30203 | 4.5MM LCP PROXIMAL TIBIA PLATE4 HOLES/82MM-LEFT | LCP PROXIMAL TIBIA PLATE4 | HRS | SYNTHES ELMIRA | 6362942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention | SCREWS |