MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2015-02-18 for INFUSE BONE GRAFT 7510200 manufactured by Medtronic Sofamor Danek Usa, Inc.
[5411057]
It was reported in a publication that the patient presented wearing an upper complete denture, seeking dental treatment for oral rehabilitation through osseointegrated implants. The patient reported an aesthetical complaint because of the increase of facial wrinkles and masticatory and phonetic difficulty due to the instability provided by the complete denture. At clinical examination, the complete absence of the upper teeth and the partial loss of the lower teeth were observed. At the preoperatively imaging examination, the computed tomography revealed the severe atrophy of the anterior area of the maxilla, at both horizontal and vertical directions. Moreover, there was a bilateral maxillary sinus pneumatization. The patient underwent reconstruction of the maxilla using synthetic bone substitute (bone ceramic 500-1000 micrometers, straumann, basel, suisse), two 1. 5 mm profile titanium plates of 1. 5 (osteosin, (b)(4)) fixed at both sides of the anterior region of maxilla with 5 mm? 1. 5 mm screws (osteosin, (b)(4)), and rhbmp-2/acs combined (infuse bone graft, 3. 2ml) prepared according to the manufacturer's recommendations and placed below the titanium plates. Post-operative medication comprised amoxicillin 875 mg + potassium clavulanate 125 mg every 12 h; paracetamol, 750 mg, every 6 h; di clofenac sodium, 50 mg, every 24 h; and 0. 12% chlorhexidine digluconate every 12 h. Trans- and post-operative period was uneventful without pain, but with edema. After 30 days, the denture was rebased with soft liner material. Eight months after rhbmp-2 surgery was planned installation of implants. After 6 months, fixed prosthesison implants was installed. Clinical and imaging examinations were performed during the post-operative period, the smile analysis not been taken. After 2 years and 5 months of following-up, a satisfactory functional and aesthetical rehabilitation was achieved.
Patient Sequence No: 1, Text Type: D, B5
[12929315]
Literature citation: z? Tola et al. Recombinant human bone morphogenetic protein type 2 in the reconstruction of atrophic maxilla: case report with long-term follow-up. Journal of indian society of periodontology. 2014 nov-dec; 18(6): 781? 785. Implanted date: (b)(6) 2008. (b)(6). (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 | 1030489-2015-00328 |
| MDR Report Key | 4524293 |
| Report Source | 03,05 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-01-31 |
| Date of Event | 2014-11-01 |
| Date Mfgr Received | 2015-01-31 |
| 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 | 7510200 |
| 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 |