FDA Adverse Event
Injury
Summary report: N
SELF TAP 4MM WIDERT SCRW INTTHRD 15
MDR report key: 1033983
·
Received April 24, 2008
Report
- Report Number
- 1649384-2008-00221
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- March 27, 2008
- Report Date
- April 24, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL HAS KEPT THE SCREW. DEVICE MANUFACTURE DATE IS UNKNOWN. INVESTIGATION PENDING.
Description of Event or Problem · 1
IN 2008, THE SALE REPRESENTATIVE REPORTED THAT A REVISION SURGERY OCCURRED IN 2007, DUE TO TWO SCREWS BACKING OUT OF THE PLATE. THE INITIAL SURGERY OCCURRED ON APPROX ONE AND A HALF MONTHS PRIOR TO ORIGINAL DATE. THE DR REMOVED THE SCREWS LEAVING EVERYTHING ELSE AS IS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELF TAP 4MM WIDERT SCRW INTTHRD 15 | ACUFIX | HWC | ABBOTT SPINE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |