FDA Adverse Event
Injury
Summary report: N
IDEAL COMPRESSION SCREW DIA. 4MM LG 50 MM
MDR report key: 840581
·
Received April 19, 2007
Report
- Report Number
- 9615741-2007-00023
- Event Type
- Injury
- Date Received
- April 19, 2007
- Report Date
- April 19, 2007
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HXX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REC'D. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE SALES REP REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: THE PHYSICIAN INSERTED THE SCREW USING A POWER DRILL. WHEN OUTSIDE SCREW HEAD LOCKED FLUSH WITH THE BONE, THE PHYSICIAN TRIED TO SCREW THE INNER SCREW HEAD AND MET RESISTANCE. THE INNER SCREW THREADS WOULD NOT ALIGN WITH THE OUTER SCREW THREADS. THE HEAD HAD DEFORMED. THE SCREW WAS EXTRACTED AND IS AVAILABLE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDEAL COMPRESSION SCREW DIA. 4MM LG 50 MM | I.CO.S. SYSTEM | HXX | NEWDEAL S.A. | * | E2UM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |