FDA Adverse Event
Malfunction
Summary report: N
VUELOCK SCREW INSERTER
MDR report key: 930655
·
Received October 17, 2007
Report
- Report Number
- 2242816-2007-00050
- Event Type
- Malfunction
- Date Received
- October 17, 2007
- Date of Event
- October 1, 2007
- Report Date
- October 9, 2007
- Manufacturer
- EBI
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT #'S MML003AG, M13038-01. MML003AG DATE OF MANUFACTURE, 03/2005. M13038-01 DATE OF MANUFACTURE, 08/2005.
Description of Event or Problem · 1
SCREW INSERTERS BROKE DURING NORMAL USE. PATIENT OUTCOME: FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VUELOCK SCREW INSERTER | HXX | EBI | MMK167L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |