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 2019-12-31 for INDUCTOS 751090001 manufactured by Medtronic Sofamor Danek Usa, Inc.
[173673177]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173673178]
It was reported that on unknown date, the patient was implanted with 12mg 1. 5mg/ml rhbmp-2/acs in conjunction with demineralized bone matrix strips. The graft was implanted at posterior lateral side in lumbar spine. On an unknown date, post-op, patient underwent a revision/extension of scoliosis correction after pseudoarthrosis.
Patient Sequence No: 1, Text Type: D, B5
[183016593]
This part is not approved for use in the united states; however a like device catalog # 7510800, pma # p000058 and udi # (b)(4) was cleared in the united states. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183016614]
The surgery, when the reported product was implanted, was about 18 months ago. Spinal screws, rods, cage, construct that were implanted in this surgery, belonged to another manufacturer. Revision surgery was performed on (b)(6) 2020. Patient current health condition were not known yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-01512 |
| MDR Report Key | 9536233 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-31 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-04-04 |
| Date Added to Maude | 2019-12-31 |
| 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 |
| 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 | 3 |
| Brand Name | INDUCTOS |
| Product Code | NEK |
| Date Received | 2019-12-31 |
| Model Number | NA |
| Catalog Number | 751090001 |
| Lot Number | 4504152844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2019-12-31 |