MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for AEQUALIS ASCEND FLEX REVERSED INSERT 36MM +9 12.5? DWF362B manufactured by .
[186559947]
This is the final report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
[186559948]
It was reported that a patient had an acromial fracture (scapular spine stress fracture) not present pre-op, 1 year after primary surgery. Patient id: (b)(6)".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000931034-2020-00038 |
| MDR Report Key | 9882236 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-26 |
| 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 | MS MAUD ANDRIOLLO |
| Manufacturer Street | 161 RUE LAVOISIER |
| Manufacturer City | MONTBONNOT SAINT-MARTIN 38330 |
| Manufacturer Country | FR |
| Manufacturer Postal | 38330 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEQUALIS ASCEND FLEX REVERSED INSERT |
| Generic Name | SHOULDER JOINT POLYMER PROSTHESIS |
| Product Code | KWS |
| Date Received | 2020-03-26 |
| Model Number | 36MM +9 12.5? |
| Catalog Number | DWF362B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |