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 XPS? CLEARVIEW - LEGEND TOOL SP14MH30T manufactured by Medtronic Xomed Inc..
[182211806]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182211807]
A health care provider (hcp) reported that during navigated transforaminal lumbar interbody fusion the burr seemed to not be advancing through the pedicle having been used to make 2 holes already with no issues. When the surgeon looked at the end of the burr, it was noticed the tip of the burr was missing. An additional intraoperative computerized tomography was conducted in order to find th e broken piece of burr. The surgeon decided that as the piece of burr was within the pedicle and not likely to become loose, to leave the piece in place as it would cause more damage to remove the broken piece. The procedure was completed and at the end of the procedure another ct spin was completed and the broken end was still within the middle of the pedicle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00138 |
| MDR Report Key | 9794407 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-12 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS? CLEARVIEW - LEGEND TOOL |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Product Code | HBE |
| Date Received | 2020-03-05 |
| Model Number | SP14MH30T |
| Catalog Number | SP14MH30T |
| Lot Number | 0218914695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-05 |