MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-11 for INFUSE BONE GRAFT X SMALL KIT 7510100 manufactured by Medtronic Sofamor Danek.
[16734474]
It was reported that the pt underwent surgery on (b) (6) 2009 in the tooth #18-19 area to grow bone using rhbmp-2acs. Pt had pre-op antibiotics, and a full course of antibiotics post-op. The pt reported pain post op.
Patient Sequence No: 1, Text Type: D, B5
[17011055]
(b) (4). A review of the certificate of analysis and packing list for the infuse bone graft did not reveal any non-conformances to specification which might contribute to the reported event. Neither 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-00792 |
| MDR Report Key | 1725373 |
| Report Source | 05 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-05-13 |
| Date of Event | 2010-01-14 |
| Date Facility Aware | 2010-01-14 |
| Report Date | 2010-05-13 |
| Date Mfgr Received | 2010-05-13 |
| Device Manufacturer Date | 2009-05-29 |
| Date Added to Maude | 2010-06-18 |
| 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 |
| 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 X SMALL KIT |
| Generic Name | INFUSE BONE GRAFT |
| Product Code | NPZ |
| Date Received | 2010-06-11 |
| Model Number | NA |
| Catalog Number | 7510100 |
| Lot Number | M110814AAI |
| ID Number | NA |
| Device Expiration Date | 2010-03-31 |
| 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 |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-11 |