FDA Adverse Event
Injury
Summary report: N
2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE.
MDR report key: 1924823
·
Received December 8, 2010
Report
- Report Number
- 3003506883-2010-00066
- Event Type
- Injury
- Date Received
- December 8, 2010
- Report Date
- November 11, 2010
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HRS
- PMA / PMN Number
- K083213
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON-GOING. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE AND PLACED IN A WALKING CAST. AFTER THE WALKING CAST WAS REMOVED, PATIENT APPARENTLY ROLLED HER ANKLE AND THE PLATE BROKE. THE PLATE WAS REMOVED AND REPLACED WITH A 3.5MM LCP 8 HOLE PLATE AND SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE. | LCP LATERAL DISTAL FIBULA PLATE | HRS | SYNTHES ELMIRA | NA | 6360525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | SCREWS |