MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-08-16 for REFLEXION TOE IMPLANT 371-02XX manufactured by Osteomed L.p..
[20213652]
Patient had received a reflexion toe implant in another facility in another state in 2003. Specific implant details on facility or date are not available. Patient complained of pain. The device was explanted. During removal, it was noted that metallosis was present in the joint capsule and surrounding tissues. The device was not returned for evaluation, however, the surgeon sent photos of the explant. Localized burnishing is visible on the head component. The uhmpwe surface of the phalanx component shows significant damage and scarring is visible on the rim of the titanium stem as well. The pattern of implant damage is consistent with an improper surgical positioning of the implant as this damage only occurs on one side of each component. The surgical technique guide provides explicit detail on how to position the implant. Device was removed. The surgeon fused the joint. Patient is currently doing fine.
Patient Sequence No: 1, Text Type: D, B5
[20378005]
Add'l model# 371-04xx and add'l catalog# 371-04xx.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2010-00008 |
| MDR Report Key | 1811984 |
| Report Source | 05,07 |
| Date Received | 2010-08-16 |
| Date of Report | 2010-08-13 |
| Date Mfgr Received | 2010-07-14 |
| Date Added to Maude | 2010-08-25 |
| 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 ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLEXION TOE IMPLANT |
| Generic Name | 1ST MPJ JOINT |
| Product Code | LZJ |
| Date Received | 2010-08-16 |
| Model Number | 371-02XX |
| Catalog Number | 371-02XX |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED L.P. |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-16 |