FDA Adverse Event
Injury
Summary report: N
SKELETAL DYNAMICS
MDR report key: 11453733
·
Received March 10, 2021
Report
- Report Number
- 3006742481-2021-00001
- Event Type
- Injury
- Date Received
- March 10, 2021
- Date of Event
- October 1, 2020
- Report Date
- February 16, 2021
- Manufacturer
- SKELETAL DYNAMICS
- Product Code
- HRS
- UDI-DI
- 00841506101590
- PMA / PMN Number
- K182492
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE PROBLEMS WERE IDENTIFIED. SEVERAL ATTEMPTS WERE MADE TO GET MORE INFORMATION, HOWEVER ALL ATTEMPTS WERE UNSUCCESSFUL. THE INSTRUCTIONS FOR USE FOR THE SYSTEM STATES: "DO NOT PERMANENTLY IMPLANT THE PRE-LOADED DRILL GUIDES, DRILL BLOCKS, OR A.I.M.ING GUIDES; THEY ARE INTENDED TO BE REMOVED PRIOR TO PEG INSERTION."
Description of Event or Problem · 1
FDA REPORT WAS RECEIVED THAT A SMALL PRE-ATTACHED DRILL GUIDE TO THE PLATE WAS INADVERTENTLY LEFT IN PLACE AT THE CONCLUSION OF WRIST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347149 | SKELETAL DYNAMICS | GEMINUS VOLAR DISTAL PLATE | HRS | SKELETAL DYNAMICS | GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, Left | 00841506101590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |