MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for RHBMP-2 manufactured by Medtronic Sofamor Danek Usa, Inc..
[130099085]
I endured a third revision of 2 previous spinal fusions on (b)(6) 2015. A/p bilateral discectomy l4/5 (l5/s1 previously fused (b)(6) 2010). During this invasive procedure (l4/5) acs with rhbmp-2 was administered. During surgery the peek cage was broken and remained this way for 72 hrs or until (b)(6) 2018 when another revision / emergency surgery was endured at l4/5; 3 weeks post-op i returned to the same hosp with low left abdominal quadrant pain. Ultrasound confirmed a mass/fluid. Biopsy inconclusive. I believe this was rhbmp-2 that leaked from the broken peek cage and has now spread through my body. I have recently been tested for cancer, hepatitis, autoimmune. All ruled out thus far. I believe i fit the adverse effects in various "thesis" within the national library of medicines. I am currently attending anesthesiology, hematology, neurosurgery, rheumatology. Please provide any insight. Thank you in advance, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082004 |
| MDR Report Key | 8151040 |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-08 |
| Date of Event | 2015-01-08 |
| Date Added to Maude | 2018-12-11 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RHBMP-2 |
| Generic Name | FILER RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN |
| Product Code | NEK |
| Date Received | 2018-12-10 |
| Device Expiration Date | 2015-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Brand Name | PEEK CAGE |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2018-12-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2018-12-10 |