MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-20 for INFUSE BONE GRAFT 7510200 manufactured by Medtronic Sofamor Danek Usa, Inc..
[1427926]
It was reported that the patient initially presented for extraction of tooth #18. Rhbmp-2/acs was used to augment the site, where a sizeable defect was present. During routine follow-up at 52 days post-op, a white circular area was noted on the crest of the ridge, approximately 1cm. The surrounding tissue was very vascular, red and swollen. The area remained unchanged in appearance until implant placement 237 days post-op. Tissue was excised from the area, with the goal of removing the white, calcified tissue. No biopsy performed at that time. Approximately one year after implant placement, the patient presented with swelling, bleeding and redness of tissue around the implant. Two months later, a biopsy and additional excision of the tissue was performed in the area of the implant #18. Pathology diagnosed the tissue as a peripheral giant cell granuloma. Post-op, the patient is healing uneventfully.
Patient Sequence No: 1, Text Type: D, B5
[8749933]
(b)(4). A review of the certificates 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 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-01084 |
| MDR Report Key | 1833024 |
| Report Source | 05 |
| Date Received | 2010-08-20 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-06-14 |
| Date Mfgr Received | 2010-07-22 |
| Device Manufacturer Date | 2007-12-10 |
| Date Added to Maude | 2010-09-15 |
| 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 | 2010-08-20 |
| Model Number | NA |
| Catalog Number | 7510200 |
| Lot Number | M110706AAB |
| ID Number | NA |
| Device Expiration Date | 2010-10-01 |
| 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. Required No Informationntervention | 2010-08-20 |