MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for EQUINOXE 320-20-00 manufactured by Exactech, Inc..
[189054696]
Pending evaluation. Concomitant device(s): 320-42-00, 6090474 - equinoxe reverse 42mm humeral liner +0; 320-10-10, 5471713 - equinoxe reverse tray adapter plate tray +10.
Patient Sequence No: 1, Text Type: N, H10
[189054697]
As reported, this was a scheduled revision of a (b)(6) y/o male patient's equinox reverse shoulder. The revision was to replace the proximal humeral tray due to a loose or broken reverse torque defining screw. We found that the screw was intact and seemed to back out after the torque defining screw was broken off per the technique.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00247 |
| MDR Report Key | 9842210 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2018-04-13 |
| 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 | KATE JACOBSON |
| Manufacturer Phone | 3523771140 |
| Manufacturer G1 | EXACTECH, INC. |
| Manufacturer Street | 2320 NW 66 CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUINOXE |
| Generic Name | REVERSE TORQUE DEFINING SCREW KIT |
| Product Code | KWT |
| Date Received | 2020-03-17 |
| Model Number | 320-20-00 |
| Catalog Number | 320-20-00 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 NW 66 COURT GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-17 |