MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2010-10-29 for INFUSE BONE GRAFT LARGE KIT 7510600 manufactured by Medtronic Sofamor Danek Usa, Inc.
[1756201]
It is reported that rhbmp-2 was used in mandibular reconstruction in this (b)(6) female following resection for ameloblastoma. The patient presented with an edentulous, residual segmental defect spanning right mandibular body to left mandibular angle and measuring 80. 7 mm. The defect was reconstructed with a 2. 4 mm reconstruction plate. A trans-cervical approach was used to create a pocket of tissue surrounding the plate wherein a cadaveric rib, previously soaked in saline, was adapted superior to the plate and secured with 12 mm bone screws on either side of the defect. A total of 24 mg rhbmp-2 /acs was placed passively into the pocket, followed by a standard layered closure. There were no surgical complications. At three months, radiographic exam revealed some calcified areas in the anterior and postero-superior aspect of the defect. Six and eight-month radiographs revealed minimal final bone formation in the segmental defect. Conventional mandibular reconstruction via iliac crest graft was successfully performed 12 months following the initial reconstruction attempt with rhbmp-2. The patient has now been fully rehabilitated with an implant-supported fixed prosthesis in the area of her segmental defect. Among the possible factors that may have lead to insufficient bone formation, the authors suggest: the absorbable collagen sponge (asc) was placed in a periosteal pocket and "tented" with cadaveric rib - since the acs lacks any structural stability, it may have collapsed around the rib, or the cadaveric rib may have provided an insufficient framework necessary for adequate bone formation.
Patient Sequence No: 1, Text Type: D, B5
[8892066]
(b)(4) - pseudarthrosis. Literature citation: glied, et al). Off-label use of rhbmp-2 for reconstruction of critical-sized mandibular defects. Three case reports. Nysdj 2010 june/july. A review of the certificates of analysis and packing list for the infuse bone graft was not possible without additional device info. Without return of the device or associated records, it is not possible to ascertain a cause for the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-01397 |
| MDR Report Key | 1893069 |
| Report Source | 01,03,05 |
| Date Received | 2010-10-29 |
| Date of Report | 2010-10-14 |
| Date of Event | 2010-06-01 |
| Date Mfgr Received | 2010-10-14 |
| Date Added to Maude | 2010-11-12 |
| 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 | 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 LARGE KIT |
| Generic Name | INFUSE BONE GRAFT |
| Product Code | NPZ |
| Date Received | 2010-10-29 |
| Model Number | NA |
| Catalog Number | 7510600 |
| 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. Required No Informationntervention | 2010-10-29 |