MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2015-05-04 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[5885645]
It was reported in a publication that a retrospective review of patients with fracture non-unions included in two prospective databases was performed at two us level 1 trauma centers from (b)(6) 1998 (center 1) or (b)(6) 2004 (center 2), respectively, until (b)(6) 2010. A total of 182 patients (102 males and 80 females) met the inclusion criteria. The mean age was 44? 13. 6 years. Sixty-eight patients were confirmed smokers, and 30 patients had a history of smoking and reported cessation prior to nonunion surgery. The remaining 84 patients reported to have never smoked. Patients were stratified into the following cohorts for analysis, based on the bone grafting modality: (1) autograft (n = 105), (2) allograft (n = 38), (3) allograft in combination with autograft (n = 16), and (4) rhbmp-2 with or without adjunctive bone grafting substitute (n = 23). The rhbmp-2 product was mixed with sterile saline and prepared immediately prior to use from a kit containing all necessary components, according to the manufacturer? S instructions. In 6 patients, rhbmp-2 was administered without bone grafting adjunct, while in the remaining 17 patients rhbmp-2 was combined with allograft. The bmp2 cases consisted of 11 tibia, 5 femur, and 7 humerus surgeries. All patients were followed postoperatively for a minimum of 12 months, or until clinical and radiographic bone healing occurred. In the bmp2 cohort, 4 patients required revision bone grafting / non-union.
Patient Sequence No: 1, Text Type: D, B5
[13262538]
Article citation: flierl et al. Outcomes and complication rates of different bone grafting modalities in long bone fracture nonunions: a retrospective cohort study in 182 patients. Journal of orthopaedic surgery and research 2013, 8:33. Patient: mean age 52 yrs (+/- 15). Patient: 7 males, 16 females. Implant date: between (b)(6) 1998 and (b)(6) 2010. (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
[34305289]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00901 |
| MDR Report Key | 4745573 |
| Report Source | 03,05 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-04-08 |
| Date of Event | 2013-09-09 |
| Date Mfgr Received | 2015-04-08 |
| Date Added to Maude | 2015-05-04 |
| 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 | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOIN |
| Product Code | MPW |
| Date Received | 2015-05-04 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2015-05-04 |