MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-31 for BUETTNER-JANZ INTERVERTEBRAL DISC RONGEUR 75-6540/20 manufactured by Waldemar Link Gmbh & Co. Kg.
[109764807]
The investigation is in process. The return of the product has been requested.
Patient Sequence No: 1, Text Type: N, H10
[109764809]
The tip of the micropituitary rongeur 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 | 3004371426-2018-00003 |
| MDR Report Key | 7556193 |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-05-31 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. REBEKKA WINTERHOFF |
| Manufacturer Street | BARKHAUSENWEG 10 |
| Manufacturer City | 22339 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22339 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BUETTNER-JANZ INTERVERTEBRAL DISC RONGEUR |
| Generic Name | RONGEUR |
| Product Code | HTF |
| Date Received | 2018-05-31 |
| Returned To Mfg | 2018-06-11 |
| Model Number | 75-6540/20 |
| Catalog Number | 75-6540/20 |
| Lot Number | B509065 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALDEMAR LINK GMBH & CO. KG |
| Manufacturer Address | BARKHAUSENWEG 10 HAMBURG, 22339 GM 22339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-31 |