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 2015-02-18 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[18066136]
It was reported in a publication that a (b)(6) boy was referred with the complaint of painless, progressive swelling in both the jaws since 6 months of age with gross facial disfigurement and obstruction of vision recently. Parents were concerned of compromised form, function and psychological impairment. There was a history of malalignment of teeth since eruption leading to difficulty in closing the mouth. There was no history of nasal obstruction, feeding difficulties, and no swelling elsewhere in the body. An incisional biopsy from both the lesions confirmed it to be jcof. After diagnosis, surgical en bloc removal and immediate reconstruction using rhbmp-2 with bone graft was planned for the mandible. For maxillary lesion, total enucleation was planned. Elective tracheostomy was done anticipating airway compromise from rhbmp-2 associated inflammatory swelling. Under general anesthesia, mandibular degloving with subperiosteal dissection was done through crevicular incision with distal release incisions extending from the angle to angle, thus to expose the mandibular lesion. The periosteum was lifted, stripped taking adequate care not to injure or tear the per iosteum. The lesion was removed as a single mass. The surrounding area was cauterized thoroughly. Fresh bleeding was induced. A titanium reconstruction plate was adapted and fixed to the residual mandible using the resected specimen as guide. Bone graft was harvested from the right 5 , 7 and 8 , ribs. The rib graft was osteotomised according to the need and secured to the reconstruction plate and host bone with titanium screws. Inside the periosteum, rhbmp-2 was supplemented to the surgical site using absorbable collagen sponge (acs) as a carrier as indicated by the manufacturer. Layer wise primary closure was done thereby creating surgical bed enriched with rhbmp-2 enclosing the grafts. The maxillary lesion was approached via the transoral route. Subperiosteal dissection was performed exposing the entire maxillary lesion. The lesion was enucleated enmass, and the layers were closed using 3-0 silk. Postoperative recovery was uneventful. On the 3 postoperative day, a large scale postoperative inflammatory response was observed. This was attributed to the use of rhbmp-2. There were no associated complications. The tracheostomy tube was maintained in place for 5 days, after which it was removed when there was no threat of compression of the trachea from the inflammatory swelling. Periodical follow-up was ensured. At 6 months of follow-up, radiologic evidence of mandibular continuity was observed, and sufficient healing of maxilla was also visualized. No recurrence was noted in a year follow-up and dental implants were placed for functional rehabilitation.
Patient Sequence No: 1, Text Type: D, B5
[18463070]
Literature citation: sm balaji. Protein-signaled guided total jaw regeneration in infantile total mandibular resection. Ann maxillofac surg. 2014 jul-dec; 4(2): 198? 200. (b)(4). 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. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00316 |
| MDR Report Key | 4522910 |
| Report Source | 01,03,05 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-01-26 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2015-01-26 |
| Date Added to Maude | 2015-02-18 |
| 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 | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| 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 |
| Generic Name | BONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT |
| Product Code | NPZ |
| Date Received | 2015-02-18 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-18 |