FDA Adverse Event
Injury
Summary report: N
35.0MM ACUTRAK 2® - 5.5 SCREW
MDR report key: 2140027
·
Received June 25, 2011
Report
- Report Number
- 3025141-2011-00021
- Event Type
- Injury
- Date Received
- June 25, 2011
- Report Date
- June 20, 2011
- Manufacturer
- ACUMED LLC
- Product Code
- HRS
- PMA / PMN Number
- K930834
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE ASSOCIATED MDR'S 3025141-2011-00020 AND 3025141-2011-00022.
Description of Event or Problem · 1
A 30.0MM ACUMED ACUTRAK 2 5.5 SCREW, A 35.0MM ACUMED ACUTRAK 2 SCREW AND A 40MM ACUTRAK 2 6/7 SCREW WERE IMPLANTED IN THE PATIENTS HIP. THE PATIENT HAD COMPLICATIONS AFTER THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 35.0MM ACUTRAK 2® - 5.5 SCREW | PLATE, FIXATION, BONE | HRS | ACUMED LLC | 30-0025-S | 210691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |