MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-01-07 for OSTEOSET T UNK manufactured by Wright Medical Technology, Inc..
[175251597]
Literature citation: visani (et al. If applicable). Treatment of chronic osteomyelitis with antibiotic-loaded bone void filler systems: an experience with hydroxyapatites calcium-sulfate biomaterials. Acta orthop. Belg. 2018; 84: 25-29. Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[175251598]
It was reported in an article by visani, et al. Titled, treatment of chronic osteomyelitis with antibiotic-loaded bone void filler systems: an experience with hydroxyapatites calcium-sulfate biomaterials, that 97 patients that received bone void filler in the treatment of chronic osteomyelitis. Six of those patients received wright medical bone void filler. Allegedly, in the whole series containing various manufacturer bone void filler, 19 patients showed recurrence of infection; in 12 a second surgical debridement was performed: 2 patients were treated with resection and bone graft, 1 with arthrodesis; in 2 cases an amputation was performed and 2 cases received no further treatment. It was possible to eradicate the infection with conservative procedure in only 4 of the recurrent cases and in 2 cases an amputation was required; the other 13 patients developed a chronic infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2020-00003 |
| MDR Report Key | 9558287 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-10 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MATTHEW PARRISH |
| Manufacturer Street | 1023 CHERRY RD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOSET T |
| Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
| Product Code | MQV |
| Date Received | 2020-01-07 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-07 |