MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-28 for PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM P30-L2-5548 manufactured by Paragon 28, Inc..
[188695227]
It was reported that the patient underwent a lapidus arthrodesis surgical procedure that utilized a paragon 28 phantom 3-hole intramedullary nail. The patient was found to have a non-union at the tarsometatarsal joint. The nail was found broken post-operatively and was revised. During the revision, the proximal portion of the nail was not removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008650117-2020-00021 |
| MDR Report Key | 9894735 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MACKENZIE BELDEN |
| Manufacturer Street | 14445 GRASSLANDS DR. |
| Manufacturer City | ENGLEWOOD, CO |
| Manufacturer Country | US |
| Manufacturer Phone | 6431300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM |
| Generic Name | ORTHOPEDIC NAIL |
| Product Code | KTW |
| Date Received | 2020-03-28 |
| Model Number | P30-L2-5548 |
| Catalog Number | P30-L2-5548 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARAGON 28, INC. |
| Manufacturer Address | 14445 GRASSLANDS DR. ENGLEWOOD, CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-28 |