FDA Adverse Event
Other
Summary report: N
RIBLOC RIB FRACTURE PLATING SYSTEM
MDR report key: 2474228
·
Received February 27, 2012
Report
- Report Number
- 3005670412-2012-00001
- Event Type
- Other
- Date Received
- February 27, 2012
- Date of Event
- February 3, 2012
- Report Date
- February 22, 2012
- Manufacturer
- ACUTE INNOVATIONS
- Product Code
- HRS
- PMA / PMN Number
- K051410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PT HAD RIB FRACTURE NON-UNIONS DUE TO A MOTOCROSS TRAUMA. ON (B)(6) 2011, THE SURGEON PLATED ONE OF THE NON-UNIONS THAT WAS SIGNIFICANTLY DISPLACED. THE PLATE WAS REPORTED BROKEN WAS REMOVED ON (B)(6) 2012. THE FOUR SCREWS THAT HAD BEEN INSTALLED WITH THE PLATE WERE ALSO REMOVED. THE FRACTURE NON-UNION WAS RE-PLATED. UNDER INVESTIGATION, F/U REPORT WITH EVAL CODES WILL BE PROVIDED.
Description of Event or Problem · 1
PLATE REMOVAL DUE TO PLATE BREAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIBLOC RIB FRACTURE PLATING SYSTEM | RIB BONE PLATE, PRODUCT CODE: HRS | HRS | ACUTE INNOVATIONS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |