FDA Adverse Event
Injury
Summary report: N
LOCKING SCREW, 2.7 X 16 MM
MDR report key: 1618273
·
Received February 25, 2010
Report
- Report Number
- 1651501-2010-00007
- Event Type
- Injury
- Date Received
- February 25, 2010
- Date of Event
- January 29, 2010
- Report Date
- February 25, 2010
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- HRS
- PMA / PMN Number
- K022325
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FOR TWO SCREWS THAT WERE USED TO SECURE THE PLATE TO THE BONE IN THE LEFT FOOT. CONCLUSION: THE PLATE AND SCREWS FUNCTIONED AS INTENDED. TAKEN OUT OF THE CONTEXT OF THE PT, IT IS IMPOSSIBLE TO DETERMINE IF THE PT'S EXPERIENCE OF PAIN WAS RELATED TO ANY GEOMETRIC OR SURFACE FEATURES OF THE PLATE AND SCREWS.
Description of Event or Problem · 1
PT COMPLAINED THAT THE PLATE AND SCREWS WERE IRRITATING HER FOOT WHEN SHE HAD HER SHOE ON. SHE HAD ASKED FOR THE DEVICE TO BE REMOVED AFTER 4 MONTHS. THE PHYSICIAN INDICATED THAT HE WAS HAPPY WITH THE RESULT. IN THE SURGERY TO REMOVE THE DEVICE, THE SURGEON INDICATED THAT THE DEVICE HAD DONE ITS JOB IN THAT BONE FUSION WAS ACHIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, 2.7 X 16 MM | BONE FIXATION PLATE (SCREW) | HRS | ASCENSION ORTHOPEDICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |