FDA Adverse Event
Injury
Summary report: N
ILIAC CREST
MDR report key: 551947
·
Received September 9, 2004
Report
- Report Number
- MW1033518
- Event Type
- Injury
- Date Received
- September 9, 2004
- Date of Event
- June 7, 2004
- Report Date
- September 9, 2004
- Manufacturer
- LIFE NET
- Product Code
- LMO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ILIAC CREST PLACED IN 2004. PT RETURNED TO SURGERY IN 3 MONTHS AND THE GRAFT WAS CRUSHED. GRAFT SITE WAS C6-C7. REQUESTED REMOVAL AND FUSION COLLAPSED DISC REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILIAC CREST | BONE GRAFT | LMO | LIFE NET | * | 032980027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |