MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for CURETTE EX1014047 manufactured by Medtronic Sofamor Danek Usa, Inc.
[93568288]
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[93568289]
It was reported that the patient presented with degenerative disc disease underwent direct lumbar interbody fusion at l4-5. Intra-op, the curette tip was broken. Product came in contact with the patient. No patient complications were reported. No fragments remained inside the patient.
Patient Sequence No: 1, Text Type: D, B5
[100941008]
Additional informatoin: product analysis: a visual and microscopic review of the curette's tip did not reveal a break. There are some witness marks on the inside of the curette. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-02378 |
| MDR Report Key | 7051977 |
| Date Received | 2017-11-22 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2018-02-22 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2017-11-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CURETTE |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2017-11-22 |
| Returned To Mfg | 2018-02-19 |
| Model Number | NA |
| Catalog Number | EX1014047 |
| Lot Number | MN14M022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |