MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for ACTIV L PE-INLAY 10MM SW992K manufactured by Aesculap Ag.
[182145900]
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
[182145901]
It was reported that there was an issue with activ l pe-inlay. According to the customer description: "a (b)(6) year old male weighing (b)(6) kg had a removal of activl artificial disc and replaced with 360 fusion". The original implantation had been performed on (b)(6) 2019. A revision surgery was necessary. Additional information has been requested. The adverse event is filed under (b)(4). Associated medwatch-reports: 9610612-2020-00059 ((b)(4) sw992k). 9610612-2020-00061 ((b)(4) sw996k).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00058 |
| MDR Report Key | 9787081 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-14 |
| Date Facility Aware | 2020-02-12 |
| Date Added to Maude | 2020-03-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ACTIV L PE-INLAY 10MM |
| Generic Name | SPINE SURGERY |
| Product Code | MJO |
| Date Received | 2020-03-04 |
| Model Number | SW992K |
| Catalog Number | SW992K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2020-03-04 |