FDA Adverse Event
Malfunction
Summary report: N
INION HEXALON ACL/PCL SCREW
MDR report key: 915757
·
Received October 4, 2004
Report
- Report Number
- 9710629-2004-00004
- Event Type
- Malfunction
- Date Received
- October 4, 2004
- Date of Event
- May 4, 2004
- Report Date
- October 1, 2004
- Manufacturer
- INION LTD.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED OF THE ATTENDING PHYSICIAN AND WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
OPERATION IN THE FEMUR. AFTER 6 WEEKS OF SURGERY, THE PATIENT CAME BACK WITH A KNEE SWELLING. THE SCREW BROKE IN SITU. DR. HAD TO GO BACK IN ARTHROSCOPICALLY AND REMOVE THE REMNANT, 2 - 3 SMALL PIECES THAT WERE FLOATING FREE IN THE KNEE JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INION HEXALON ACL/PCL SCREW | BONE FIXATION SCREW | HWC | INION LTD. | ACL-4105 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |