MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-12 for HAMMERTUBE SYSTEM manufactured by Paragon 28, Inc..
[179225871]
Devices are not expected to be returned for the manufacturer review/investigation. Identifying information, such as the part number or lot number of the plates, was not reported to paragon 28. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[179225872]
During post-market surveillance activities, paragon 28 became aware that a paragon 28 hammertube implant broke post-operatively and was revised. It was reported that the hammertube break was caused by a lack of soft tissue release within the area. The surgeon used a 2. 0mm screw to revise the joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008650117-2020-00006 |
| MDR Report Key | 9703670 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-12 |
| 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 | HAMMERTUBE SYSTEM |
| Generic Name | INTERPHALANGEAL IMPLANT |
| Product Code | HTY |
| Date Received | 2020-02-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-12 |