FDA Adverse Event
Other
Summary report: N
RIBLOC RIB FRACTURE PLATING SYSTEM
MDR report key: 2706467
·
Received August 15, 2012
Report
- Report Number
- 3005670412-2012-00006
- Event Type
- Other
- Date Received
- August 15, 2012
- Date of Event
- June 27, 2012
- Report Date
- July 9, 2012
- Manufacturer
- ACUTE INNOVATIONS
- Product Code
- HRS
- PMA / PMN Number
- K051410
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PATIENT HAD THREE PLATES INSTALLED ON (B)(6) 2010. ON (B)(6) 2012, THE PLATES AND SCREWS USED TO INSTALL THE PLATES WERE REMOVED AT THE PATIENTS REQUEST DUE TO PAIN. THE PLATES WERE EXAMINED AND SUSPECTED OF BEING THE WRONG SIZE FOR THE PATIENT. NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL MDR'S ASSOCIATED WITH THIS EVENT ARE: 3005670412-2012-00004 AND 3005670412-2012-00007. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
PLATE WAS REPORTED TO BE CAUSING PATIENT PAIN AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIBLOC RIB FRACTURE PLATING SYSTEM | RIB BONE PLATE | HRS | ACUTE INNOVATIONS | RBP1102 | L0906010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |