FDA Adverse Event
Injury
Summary report: N
28MM SLIC SCREW® PACK
MDR report key: 3973059
·
Received August 1, 2014
Report
- Report Number
- 3025141-2014-00179
- Event Type
- Injury
- Date Received
- August 1, 2014
- Report Date
- August 4, 2014
- Manufacturer
- ACUMED LLC
- Product Code
- HWC
- PMA / PMN Number
- K111608
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SCREW IS DISSOCIATED AT THE JOINT. THERE IS SLIGHT DEFORMATION AROUND THE HEX OF BOTH THE DISTAL AND PROXIMAL SCREW PORTIONS. THERE IS ALSO SLIGHT DEFORMATION AT THE JOINT PORTION OF THE PROXIMAL SCREW SECTION. CONCLUSION - A CONCLUSION CANNOT BE DRAWN BASED ON THE LACK OF INFORMATION CONCERNING THE CIRCUMSTANCES OF THIS SCREW BREAK.
Description of Event or Problem · 1
EIGHT WEEKS AFTER IMPLANTATION, THE SLIC SCREW DISSOCIATED AT THE JOINT. THE DISSOCIATED SCREW WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449810 | 28MM SLIC SCREW® PACK | SCREW, FIXATION, BONE | HWC | ACUMED LLC | 46-0007-S | 312230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |