MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-23 for COLLECT.NO.QAS KNEE IMPLANTS VEGA AE-QAS-K521-56 manufactured by Aesculap Implant Systems.
[103440341]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[103440342]
Country of complaint: usa. It was reported that the original surgery was performed on (b)(6) 2017, but the surgeon noticed that the tibia had loosened. Revision surgery date is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00127 |
| MDR Report Key | 7365481 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-22 |
| Date of Event | 2018-04-24 |
| Date Facility Aware | 2018-03-20 |
| Date Mfgr Received | 2018-03-14 |
| Date Added to Maude | 2018-03-23 |
| 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. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLECT.NO.QAS KNEE IMPLANTS VEGA |
| Generic Name | GLIDING SURFACES/PATELLAS VEGA SYST |
| Product Code | HTG |
| Date Received | 2018-03-23 |
| Model Number | AE-QAS-K521-56 |
| Catalog Number | AE-QAS-K521-56 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-23 |