MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-01-01 for INDUCTOS UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[131761540]
Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131761541]
It was reported in the literature titled? Treatment of pediatric spinal deformity with use of recombinant human bone morphogenetic protein-2? That 13 children patients (4 females and 9 males) with a mean age of 11. 2 years underwent spinal rhbmp-2 surgery. Rhbmp-2 was used in both primary and revision surgery in patients. Post-op, complications occurred where 3 patients had an increased body temperature and 1 had prolonged wound and in one of these patients an extensive postoperative hematoma occurred. In one case revision surgery due to the development of an extensive hematoma was necessary after rhbmp-2 application in this study. This complication was thought to be due to the use of rhbmp-2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-01722 |
| MDR Report Key | 8207429 |
| Report Source | LITERATURE |
| Date Received | 2019-01-01 |
| Date of Report | 2019-01-01 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2019-01-01 |
| 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 |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2019-01-01 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other; 2. Required No Informationntervention | 2019-01-01 |