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 2020-03-05 for QUINTEX SEMICONSTRAINED SCREW 4.0X16MM SC503T manufactured by Aesculap Ag.
[182558699]
Associated medwatch reports: 9610612-2020-00058 ((b)(4) sc503t). 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
[182558700]
It was reported that there was an issue with a quintex semiconstrained screw. According to the reporter several quintex screws broke. The 40mm hybrid plate was held in place by one plate holding pin, in the central hole. The surgeon used the double drill guide, set to 16mm, and drilled the screw holes. He then placed the semi-constrained 16mm screws. When the screw was seated in the plate, he pulled the screwdriver out and the small silver metal locking circle came out of the head of the screw. This happened twice, and the screws had to be replaced. Next the surgeon had only screwed the screw halfway down, not into the plate, and stopped for an x-ray, when he removed the screwdriver the metal locking circle came out again. When i checked the removed screws at the end of the case, i also saw that on one of the screws, four of the five petals forming the screw head had broken off. The procedure was a c4-6 two level anterior cervical decompression and fusion (acdf). There was no patient harm. This malfunction prolonged the surgery for 10 minutes. Additional patient information is not available. The malfunction is filed under aag reference (b)(4). Associated medwatch reports: 9610612-2020-00058 ((b)(4) sc503t).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00057 |
| MDR Report Key | 9794393 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-05 |
| 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 | QUINTEX SEMICONSTRAINED SCREW 4.0X16MM |
| Generic Name | IMPLANTS CERVICAL STABILISATIO |
| Product Code | KWQ |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-02-20 |
| Model Number | SC503T |
| Catalog Number | SC503T |
| Lot Number | 52520364 |
| 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, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |