FDA Adverse Event
Injury
Summary report: N
NI
MDR report key: 2143669
·
Received April 19, 2006
Report
- Report Number
- 2939274-2006-00007
- Event Type
- Injury
- Date Received
- April 19, 2006
- Date of Event
- March 14, 2006
- Report Date
- March 21, 2006
- Manufacturer
- SYNTHES (USA)
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. NO EVAL COULD BE MADE, NO CONCLUSION COULD BE DRAWN AS NO DEVICE HAS BEEN RECEIVED. SYNTHES IS UNABLE TO DETERMINE THE MANUFACTURE DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
NORIAN CRS USED ON MESH FOR A CRANIOTOMY WAS REMOVED BECAUSE OF MATERIAL OOZING OUT. SURGEON THOUGHT IT MAY BE INFECTED AND FOUND THAT IT HAD NOT SET 1 WEEK POST IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | NI | MQV | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | MESH |