FDA Adverse Event
Malfunction
Summary report: N
SOLITAIRE PEEK-OPTIMA IMPLANTS
MDR report key: 1406040
·
Received June 24, 2009
Report
- Report Number
- 2242816-2009-00056
- Event Type
- Malfunction
- Date Received
- June 24, 2009
- Date of Event
- May 29, 2009
- Report Date
- June 10, 2009
- Manufacturer
- EBI, LLC
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITONAL PARTS RECIEVED INVOLVED IN EVENT:CATALOG # LOT # MFG DATE1400-1012 102610 08/2007
Description of Event or Problem · 1
SCREW HEADS STRIPPED. ROUNDED HEX OFF. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED A S A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLITAIRE PEEK-OPTIMA IMPLANTS | SOLITAIRE 25MM SCREW | HWC | EBI, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |