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 2019-12-16 for ENNOVATE SCREW TAP F/D4.5MM SZ254R manufactured by Aesculap Ag.
[174276343]
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
[174276344]
It was reported that there was an issue with ennovate screw tap f/d4. 5mm. It was reported that the tap broke during removal from vertebral body s1. The broken working end could be removed completely. The broken piece was removed with a special removal set which was used against the drilling direction. It was an spondylolisthesis surgery. The surgery was finished successfully and the patient is well. This event prolonged the surgery for 30 minutes. Additional information was not provided. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00853 |
| MDR Report Key | 9476222 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-16 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2018-02-02 |
| Date Added to Maude | 2019-12-16 |
| 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 | ENNOVATE SCREW TAP F/D4.5MM |
| Generic Name | SPINE SURGERY |
| Product Code | HWX |
| Date Received | 2019-12-16 |
| Returned To Mfg | 2019-12-12 |
| Model Number | SZ254R |
| Catalog Number | SZ254R |
| Lot Number | 52396703 |
| 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 | 1. Required No Informationntervention | 2019-12-16 |