MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-03-23 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[14889258]
It was reported that the patient presented with recurring unicameral bone cyst in the proximal femur. Through an earlier incision, the patient was treated with open curettage of the left proximal femur, which was then packed with a mixture of left iliac crest bone graft, demineralized bone matrix, and 12 mg of rhbmp-2 delivered on a collagen sponge matrix. The patient had an unremarkable hospital stay and was discharged 2 days later. Four days after the procedure, the patient was presented at the emergency department with left leg pain and swelling. Patient appeared in no acute distress, with normal vital signs , neurovascular function, range of motion, and blood panels. Her left thigh was seen to be at least twice the size of her right thigh. Area was swollen and mildly tight but compartments were soft and remained easily compressible. Superficially, her incision appeared to be healing well with no surrounding erythema, purulent material, or tenderness. Radiographs showed evidence of significant swelling in soft tissues medially and laterally, although no new bony or hardware abnormalities were noted. The patient was admitted to the hospital for observation with discharge the following day because of the decreased swelling. Follow-up three days later revealed a slight decrease in left thigh swelling. At her most recent follow-up evaluation, 4 months later, the patient continued to heal well with her symptoms fully resolved.
Patient Sequence No: 1, Text Type: D, B5
[15521546]
(b) (4). Literature article citation: macdonald et al. Exaggerated inflammatory response after use of recombinant bone morphogenic protein in recurrent unicameral bone cyst. Pediatric orthopedics 2010; (vol 30. No. 2). A review of the certificates of analysis and packing list for the infuse bone graft was not possible without additional device information. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-00389 |
| MDR Report Key | 1639930 |
| Report Source | 03,05 |
| Date Received | 2010-03-23 |
| Date of Report | 2010-02-26 |
| Date of Event | 2010-03-01 |
| Report Date | 2010-02-26 |
| Date Mfgr Received | 2010-02-26 |
| Date Added to Maude | 2010-03-30 |
| 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 | 1800 PYRAMID PLACE |
| 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 |
| Generic Name | INFUSE BONE GRAFT |
| Product Code | MPW |
| Date Received | 2010-03-23 |
| Model Number | NA |
| Catalog Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2010-03-23 |