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 |