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 2020-03-11 for COLLECT.NO.QAS SPINE CERVICAL STABILIS. AE-QAS-SP40 manufactured by Aesculap Ag.
[183100475]
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
[183100476]
It was reported that there was an issue with a product of spine cervical stabilisation. The article code is not available until today. Initial surgery: (b)(6) 2010, due to a road accident. The surgery was decompression of t4-t6 and to a expedium + summit c5-t12 with bars inserting. On (b)(6) 2010, he was transferred to the spinal unit, with complete paraplegia level t2 and spasms at limbs of moderate intensity; he was dismissed on (b)(6) 2010. Due to further investigations on november 2016 it was highlighted a breakage of connection between cervical and dorsal part and breakage of the bars. This caused an additional medical intervention for removing synthesis parts. A revision surgery was necessary. Revision surgery: (b)(6) 2016. Additional information has been requested but not yet received as of this report. The adverse event/malfunction is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00074 |
| MDR Report Key | 9819497 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-11 |
| 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 | COLLECT.NO.QAS SPINE CERVICAL STABILIS. |
| Generic Name | IMPLANTS CERVICAL STABILISATION |
| Product Code | KWQ |
| Date Received | 2020-03-11 |
| Model Number | AE-QAS-SP40 |
| Catalog Number | AE-QAS-SP40 |
| 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. Required No Informationntervention | 2020-03-11 |