MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for BUTTNER JANZ IVD PITUITARY RONGEUR 75-6540/20 manufactured by Linkbio Orthopedics.
[106449718]
Patient Sequence No: 1, Text Type: N, H10
[106449719]
The tip of the micropituitary ronguer broke off at its jaw during the procedure. Entire surgical team was made aware. A replacement rongeur was requested and brought into the room. A portion of the instrument was seen on x-ray by attending surgeon. Attempts were made to retrieve the part but was sitting deep inside the disc space. Artifact was felt to be in a safe position and was left. Patient and family were made aware of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7457717 |
| MDR Report Key | 7457717 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-04-05 |
| Report Date | 2018-04-18 |
| Date Reported to FDA | 2018-04-18 |
| Date Reported to Mfgr | 2018-04-18 |
| Date Added to Maude | 2018-04-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUTTNER JANZ IVD PITUITARY RONGEUR |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2018-04-25 |
| Model Number | 75-6540/20 |
| Catalog Number | 75-6540/20 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINKBIO ORTHOPEDICS |
| Manufacturer Address | 101 ROUNDHILL DRIVE, 2ND FLOOR ROCKAWAY NJ 07866 US 07866 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-25 |