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..
[21993655]
(b)(4). Literature citation: glied, et al). Off-label use of rhmbp-2 for reconstruction of critical-sized mandibular defects: three case reports. 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. (b)(4): pseudarthrosis.
Patient Sequence No: 1, Text Type: N, H10
[22096306]
It was reported that rhbmp-2 was used in this patient who was diagnosed with a fractured mandibular reconstruction plate three years after a mandibular resection for osteomyelitis. A trans-cervical approach was used to create a pocket of tissue surrounding a reconstruction plate wherein a cadaveric rib, previously soaked in saline, was adapted superior to the plate and secured with 12mm bone screws on either side of the defect. Twenty-four mg rhbmp-2/acs was placed passively into the pocket, followed by a standard layered closure. The surgery was uneventful. Three days into recovery, the patient complained of increasing pain and a feeling that she was losing her voice. Examination, including fiberoptic laryngoscopy, revealed no vocal cord or laryngeal edema or abnormalities; the problem resolved spontaneously in the following two days. The patient was discharged from the hospital seven days after surgery. She was seen in the following weeks; the soft tissues were healing well. At 8 and 12 months following surgery, panoramic radiograph revealed little bone formation in the defect, with some calcifications superiorly. The patient elected to undergo conventional reconstruction, but has yet to do so. 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
| Report Number | 1030489-2010-01398 |
| MDR Report Key | 1893068 |
| 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 | 2010-11-10 |
| 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 |