MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2014-12-18 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[19763693]
It was reported that infants underwent nasoalveolar molding/gingivoperiosteoplasty (gpp) with bmp-2 on a resorbable matrix for primary alveolar repair. Long-term follow-up (10 years) was compared for 1) no gpp, 2) gpp only or 3) gpp with bmp-2 by analyzing alveolar bone, tooth eruption, and maxillary growth. For the three primary unilateral cleft repair patient groups: 1) no gpp (n =15), 2) gpp only (n = 15) or 3) gpp with bmp-2 (n = 10) follow-up studies were performed at least 10 years after the procedure. There was one gpp patient lost to follow-up. The study recorded need for secondary alveolar bone grafting, timing of tooth eruption, and clinical evidence of maxillary hypoplasia. New-tom scans were used to analyze dentition, bone volume and bone density. Greater bone graft volume/density was seen at the cleft site in group 3 (gpp/bmp-2) compared to group 2 (gpp only) (86% vs 42% bone fill). Secondary alveolar bone grafting after expansion was necessary in group 1 (100%); group 2 (73%); group 3 (20%). Two patients in group 3 (gpp/bmp-2) underwent le fort i distraction at age 13. In the other groups there were no patients, to date, who have undergone le fort i distraction. Clinical evidence of maxillary hypoplasia was seen in group 1 (40%); group 2 (53%); group 3 (60%). It was concluded that after mid-childhood but prior to skeletal maturity, gpp/bmp-2 primary alveolar cleft repairs showed similar tooth eruption, improved bone fill of the cleft site, less need for secondary alveolar grafting. However, data thus far shows poorer midface growth compared to no gpp at primary cleft repair. Six patients in the bmp cohort demonstrated clinical evidence of maxillary hypoplasia.
Patient Sequence No: 1, Text Type: D, B5
[19863101]
(b)(6). (b)(4). Maxillary hypoplasia. Neither the device nor applicable imaging study films or patient medical records 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/used 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 | 1030489-2014-04792 |
| MDR Report Key | 4343540 |
| Report Source | 03 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-26 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2014-11-26 |
| Date Added to Maude | 2014-12-19 |
| 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 | 2014-12-18 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2014-12-18 |