MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for TENOTAC SOFT TISSUE FIXATION SYSTEM P42-022-0065 manufactured by Paragon 28, Inc..
[188694692]
During evaluation and investigation, the implants were not available for analysis. The implants are not expected to be returned for the manufacturer review/investigation. The device history records could not be reviewed because the affected lot number 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
[188694693]
A tenotac implant was used to correct a cross-over toe in a surgery on (b)(6) 2019. It was reported that upon correction of the deformity, the tendon was very tight, making implantation difficult. The implant did not hold the tendon in place post-operatively and there was a recurrence of the deformity. It was reported that on (b)(6) 2020, a revision surgery was performed to correct the recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008650117-2020-00010 |
| MDR Report Key | 9838647 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | TENOTAC SOFT TISSUE FIXATION SYSTEM |
| Generic Name | SOFT TISSUE FIXATION DEVICE |
| Product Code | MBI |
| Date Received | 2020-03-17 |
| Model Number | P42-022-0065 |
| Catalog Number | P42-022-0065 |
| 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 | 2020-03-17 |