MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for LYOPLANT ONLAY 2.5X2.5CM 1067010 manufactured by Aesculap Ag.
[180809582]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if applicable.
Patient Sequence No: 1, Text Type: N, H10
[180809583]
It was reported that there was an issue with a lyoplant onlay, per information provided by medwatch 5092414. The patient had a dura substitute, lyoplant, initially implanted for chiari decompression. Sometime later, the patient presented with subdural hygromas and septic meningitis. This resulted in the need for hospitalization. Additional information was not received. The adverse event is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00049 |
| MDR Report Key | 9751419 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-12 |
| Date Facility Aware | 2020-02-03 |
| Report Date | 2020-01-22 |
| Date Reported to FDA | 2020-01-22 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYOPLANT ONLAY 2.5X2.5CM |
| Generic Name | DURA REPLACEMENT |
| Product Code | GXQ |
| Date Received | 2020-02-25 |
| Model Number | 1067010 |
| Catalog Number | 1067010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-25 |