MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for LYOPLANT ONLAY 5.0X5.0CM 1067020 manufactured by Aesculap Ag.
[182304473]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[182304494]
It was reported that there was an issue with a lyoplant onlay, per information from medwatch 5092415. It was reported that the patient had a lyoplant graft for chiari decompression with subsequent subdural hygromas and aseptic meningitis. It is reported this was a serious injury that had the outcome of hospitalization. An additional medical intervention was necessary. Additional information was not provided nor available. Additional patient and reporter information is not available. The adverse event is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00029 |
| MDR Report Key | 9781808 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-10-30 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-03-07 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| 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 | LYOPLANT ONLAY 5.0X5.0CM |
| Generic Name | DURA REPLACEMENT |
| Product Code | GXQ |
| Date Received | 2020-03-03 |
| Model Number | 1067020 |
| Catalog Number | 1067020 |
| Lot Number | 219075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-03 |