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 2020-02-12 for S4 SET SCREW NEW VERSION SW790T manufactured by Aesculap Ag.
[179469010]
If addditional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[179469011]
It was reported that there was an issue with s4 set screw. According to the customer complaint. "l4/l5 fixation using s4 and sri(spondylolisthesis reduction instrument). When inserting set screws into the screws in l5, the rod was slightly elevated in l4 screws and there was a slight gap between the rod and the screws. In right l4, the surgeon attempted to screw in the set screw using a set screw starter, but the set screw rotated idly, so he removed the set screw in question to replace it with a brand new one. The surgeon used two set screws in the left screw of l4, but both rotated idly in the left side, too. Finally, for the right l4 screw, the surgeon managed to fix the second set screw, and it was successful. For the left, the surgeon attempted carefully to fix one of the two failed set screws, and he succeeded in finally tightening the set screw. There was no need for replacement of pedicle screws. It is unknown exactly how long the surgical procedure was delayed. There was no patient harm. Additional information was not provided nor available / was not available. Additional patient information is not available. The adverse event is filed under (b)(4). Associated medwatch-reports: 9610612-2019-00950 ((b)(4) sw790t).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00949 |
| MDR Report Key | 9702355 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2014-06-30 |
| Date Added to Maude | 2020-02-12 |
| 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, |
| Manufacturer Country | GM |
| 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 | SPINE SURGERY |
| Product Code | MNI |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-03-16 |
| Model Number | SW790T |
| Catalog Number | SW790T |
| Lot Number | 52044561 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |