MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for QUINTEX SEMICONSTRAINED SCREW 4.0X18MM SC504T manufactured by Aesculap Ag.
[186211445]
General information: the screw arrived in decontaminated condition. Consequences for the patient according to the available information, there were no negative consequences for the patient. Investigation: the received screw exhibits no defects, the locking ring is in its correct position investigation: we made a visual inspection of the complained screw. Except a slight wear on the thread, most likely caused by the screwing in and out of the screw, we found no abnormalities or defects. The locking ring is in its correct position batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production. There are no further complaints with this lot at hand conclusion and root cause: the root cause for the problem is most probably usage related. Rationale: the popping out of locking rings is normally caused by driving the screwdriver in the head of the screw with a wrong (too low) angle. The complaint sample has its locking ring in the correct position, we found no deviation to the specification (maybe the ring was pushed in the head of the screw again after surgery). According to sop (b)(4) (corrective action & preventive action) a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[186211446]
It was reported that there was an issue with quintex semi-constrained screw. It was reported that the reported torn out of the anchorage when screwing in. The malfunction occurred during a spinal c7-th1 procedure. There was no surgical delay and no patient injury. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00097 |
| MDR Report Key | 9888729 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-09-27 |
| Date Added to Maude | 2020-03-27 |
| 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 4.0X18MM |
| Generic Name | SPINE SURGERY |
| Product Code | KWQ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-01-30 |
| Model Number | SC504T |
| Catalog Number | SC504T |
| Lot Number | 52550208 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-27 |