MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-07 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[5623271]
It was reported that in (b)(6) 2010, the patient sustained a right humerus fracture and she underwent a fusion surgery with a plate. Several month later, the bone broke again and the patient had another fusion surgery with plate and screws. In (b)(6) 2012, bone broke again and she underwent fusion surgery using rhbmp-2/acs. Post-op, the patient has developed joint deterioration, swelling, pain, eye problems, a lesion on her skin, and extreme fatigue. Patient is undergoing many tests to determine the cause of her symptoms, but no answer has been found. Her blood work was negative for lupus and rheumatoid arthritis. The patient has seen a lung specialist, a dermatologist, an eye specialist, and an orthopedic surgeon. The orthopedic surgeon reportedly said that "something is attacking her joints. " an mri reportedly indicated that "something is attacking her joints" and the physician thinks there is an autoimmune problem. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13222587]
(b)(4). 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. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00735 |
| MDR Report Key | 4665625 |
| Report Source | 04 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-03-09 |
| Date Mfgr Received | 2015-03-09 |
| Date Added to Maude | 2015-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| 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, OSTEOIN |
| Product Code | MPW |
| Date Received | 2015-04-07 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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. Required No Informationntervention | 2015-04-07 |