MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-13 for MORPHOGENIC BONE GROWTH FACTOR manufactured by Medtronic.
[21289558]
Recurrent bone growth after initial lumbar fusion done in 2007. Pt has initial lumbar fusion with medtronic morphogenic bone growth factor in 2007. Getting recurrent excess bone growth requiring surgical intervention due to severe l5 foraminal stenosis and nerve root compromise. Excess bone growth occurred in 2008, requiring surgical intervention. Excess bone growth again in 2010, requiring surgical intervention. Now third episode of bone growth with impending surgical intervention. All surgical intervention at same site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026945 |
| MDR Report Key | 2750460 |
| Date Received | 2012-09-13 |
| Date of Report | 2012-09-13 |
| Date of Event | 2012-09-13 |
| Date Added to Maude | 2012-09-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORPHOGENIC BONE GROWTH FACTOR |
| Generic Name | NONE |
| Product Code | MPW |
| Date Received | 2012-09-13 |
| Lot Number | UNK |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2012-09-13 |