FDA Adverse Event
Injury
Summary report: N
IMPLATE
MDR report key: 12457220
·
Received September 10, 2021
Report
- Report Number
- 3006742481-2021-00008
- Event Type
- Injury
- Date Received
- September 10, 2021
- Date of Event
- August 5, 2021
- Report Date
- August 12, 2021
- Manufacturer
- SKELETAL DYNAMICS
- Product Code
- HSB
- UDI-DI
- 00841506102153
- PMA / PMN Number
- K092720
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT PART IS NOT EXPECTED TO BE RETURNED FOR REVIEW/INVESTIGATION. DEVICE LOT NUMBER WAS NOT PROVIDED AND THEREFORE A THOROUGH REVIEW OF DEVICE RECORDS COULD NOT BE CONDUCTED. ATTEMPTS MADE TO GET ADDITIONAL INFORMATION WERE UNSUCCESSFUL. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN. NO TREND HAS BEEN IDENTIFIED AT THE TIME OF THIS SUBMISSION. THIS TYPE OF FAILURE MODE WILL CONTINUE TO BE MONITORED.
Description of Event or Problem · 1
SCREW LOOSENING POST-OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1351546 | IMPLATE | WRIST ARTHRODESIS NAIL SYSTEM | HSB | SKELETAL DYNAMICS | IMPLATE Nail, Metacarpal, Mini | 00841506102153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |