MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-03 for INFUSE BONE GRAFT 7510200 manufactured by Medtronic Sofamor Danek Usa, Inc.
[143935165]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the r eported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143935166]
It was reported that the patient underwent oblique lateral interbody fusion and posterior fusion surgery at l2-3 due to intervertebral disc degeneration and lumbar low back pain. At approximately 18 months post-op, patient symptomatic and showing signs of an inflammatory response (muscle aches, weakness, joint pain, back pain, difficulty walking, weakness and numbness, depression and anxiety). Surgeon describes response as? Over-exuberant osteoclast activation from bone morphogenetic protein (bmp)?. Additionally, there have been no reports of indications of any active infection from the time of implantation. On (b)(6) 2017: patient underwent a posterior pedicular biopsy and redo l2-3 laminectomy for recurrent stenosis and a lyric lesion in his vertebra. Result: wound was normal, cultures grew no organisms and had negative gram stain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00508 |
| MDR Report Key | 8576888 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2019-05-03 |
| 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 | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2019-05-03 |
| Model Number | NA |
| Catalog Number | 7510200 |
| Lot Number | M111613AAH |
| Device Expiration Date | 2019-02-28 |
| 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 | 2019-05-03 |