MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-07 for UNIVATION X IMPLANT SET ST0541 manufactured by Aesculap Implant Systems.
[76966614]
Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u. S. (b)(4). Manufacturing site evaluation: evaluation on-going. Device was missing from set.
Patient Sequence No: 1, Text Type: N, H10
[76966615]
Country of complaint: usa. It was reported that the surgeon did not receive all the implants requested to perform a univation procedure. Due to the part of a missing implant set the surgeon had to perform a tkr (total knee replacement) instead. There was a twenty minute delay in surgery while trying to locate a second implant tray. There was no harm to the patient, other than having to under go a tkr (total knee replacement) because the product could not be located to perform a univation procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2017-00005 |
| MDR Report Key | 6618299 |
| Date Received | 2017-06-07 |
| Date of Report | 2017-06-30 |
| Date Facility Aware | 2017-06-07 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2017-06-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 0 |
| Brand Name | UNIVATION X IMPLANT SET |
| Generic Name | IMPLANTS LOAN SETS KNEE |
| Product Code | OOG |
| Date Received | 2017-06-07 |
| Model Number | ST0541 |
| Catalog Number | ST0541 |
| 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 | 2017-06-07 |