MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-11 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[4692336]
It was reported that the patient underwent an unspecified surgery in the lower jaw using rhbmp-2/acs. Post-op, the patient developed a swollen lower jaw that has been on-going for 2. 5 weeks since the surgery. The surgeon informed the patient that swelling could last 3-4 weeks. No additional information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
[11934111]
(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 | 1030489-2014-03426 |
| MDR Report Key | 3999966 |
| Report Source | 04 |
| Date Received | 2014-08-11 |
| Date of Report | 2014-07-14 |
| Date Mfgr Received | 2014-07-14 |
| Date Added to Maude | 2014-08-12 |
| 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 | BONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT |
| Product Code | NPZ |
| Date Received | 2014-08-11 |
| 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. Other | 2014-08-11 |