MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for OSTEOVATION 390-6002 manufactured by Osteomed.
[108091603]
On (b)(6) 2018, osteomed was notified of an incident concerning an abscess that occurred in a patient with osteomed implants. Per the sales representative, the patient received multiple implants as part of a lefort i osteotomy procedure performed on (b)(6) 2018. Almost one (1) month following the procedure, the patient experienced right cheek swelling. On (b)(6) 2018, the area of the surgery was opened to locate the abscess. The area was allowed to drain. Following drainage, the area was irrigated. A culture was taken and sent for testing. The results did not identify any organisms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-2018-00020 |
| MDR Report Key | 7507719 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-17 |
| Date Added to Maude | 2018-05-11 |
| 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 | MRS. LATOIA PHILLIPS |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer G1 | OSTEOMED |
| Manufacturer Street | 385 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSTEOVATION |
| Generic Name | OSTEOVATION RMX 10CC |
| Product Code | GXP |
| Date Received | 2018-05-11 |
| Catalog Number | 390-6002 |
| Lot Number | 16120701 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | 3885 ARAPAHO ROAD ADDISON TX 75001 US 75001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-11 |