MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-13 for BIOACTION UNK manufactured by Osteomed L.p..
[726336]
Pt complained of painful cyst and loss of range of motion months after implant. Determined pt had not gone to physical therapy. Dr asked if implant had shifted. X-ray at early post-op shows placement cuts were not co-planer. Surgical technique guide asks that cuts, be made at 90 degree to sagittal & transverse. One of the cuts is at 45 degree angle.
Patient Sequence No: 1, Text Type: D, B5
[7879027]
Device discarded - not returned to company. Dr. Did not perform cut per surgical technique guide. Pt did not do physical therapy as directed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2007-00009 |
| MDR Report Key | 911412 |
| Report Source | 05 |
| Date Received | 2007-09-13 |
| Date of Report | 2007-09-13 |
| Date of Event | 2007-07-27 |
| Date Mfgr Received | 2007-08-14 |
| Date Added to Maude | 2007-09-18 |
| 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 Street | 3885 ARAPAHO RD. |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOACTION |
| Generic Name | 1ST MPJ IMPLANT |
| Product Code | LZJ |
| Date Received | 2007-09-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 887223 |
| Manufacturer | OSTEOMED L.P. |
| Manufacturer Address | ADDISON TX 75001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-13 |