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 2020-03-13 for S4 SET SCREW NEW VERSION SW790T manufactured by Aesculap Ag.
[183374592]
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
[183374593]
It was reported that there was an issue with s4 set screw new version. The following information was reported: the surgeon was unable to tighten the set screw using the torque wrench up to 10nm. After replacing the screw and the set screw the procedure was done with no problem using the same torque wrench. Surgery delay was less than 15 minutes. Additional information was not provided. The malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2020-00073 (400465325 + sw790t)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00072 |
| MDR Report Key | 9829683 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-07-25 |
| Date Added to Maude | 2020-03-13 |
| 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 | S4 SET SCREW NEW VERSION |
| Generic Name | IMPLANTS POSTERIOR STAB. |
| Product Code | MNI |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-09 |
| Model Number | SW790T |
| Catalog Number | SW790T |
| Lot Number | 52446850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-13 |