MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-05-28 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[1402586]
It was reported that the pt underwent a cleft repair procedure using rhbmp-2/acs. It was reported that the cleft site repair failed to meet radiographic criteria of dental arch fusion; however, the aesthetic result was pleasing, and possibility for subsequent grafting exists. Per the reporter, failure in this particular case was attributed to excessive irrigation of the implant site before final closure, leading to a "dilution effect" of protein from the sponge. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8576440]
(b) (4). Non-union. Literature article citation: fallucco et al. Primary reconstruction of alveolar clefts using recombinant human bone morphogenic protein-2; clinical and radiographic outcomes. The journal of craniofacial surgery 2009; 1759-1764. A review of the certificates of analysis and packing list for the infuse bone graft was not possible without additional device info. Neither the device nor films of applicable imaging studies were returned to the manufacturer for eval. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-00755 |
| MDR Report Key | 1705940 |
| Report Source | 03,05 |
| Date Received | 2010-05-28 |
| Date of Report | 2010-04-28 |
| Date of Event | 2009-01-23 |
| Date Facility Aware | 2009-01-23 |
| Report Date | 2010-04-28 |
| Date Mfgr Received | 2010-04-28 |
| Date Added to Maude | 2010-06-04 |
| 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 | 3 |
| Manufacturer Contact | CHAD ASHTON |
| 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 SWINNEA 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 | INFUSE BONE GRAFT |
| Product Code | NPZ |
| Date Received | 2010-05-28 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 4340 SWINNEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-28 |