MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-03-05 for METATARSAL HEAD LONG OR METATARSAL HEAL XLONG 370-0205/370-0207 manufactured by Osteomed.
[3196557]
The reflexion implant was implanted in the left big toe in 2010 by a doctor at the (b)(6), in (b)(6) 2012, the patient came back in the va outpatient clinic and saw another doctor who was not the doctor who originally implanted the reflexion. The patient complained of persistent pain and loss of motion in his left hallux (big toe) where the reflexion implant was placed in 2010. The second doctor explanted the part on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[10555773]
It was reported by our territory manager that after viewing the x-rays, the doctor observed that the left reflexion implant was dislocated and there was a fracture in the cortex of the proximal phalanx. Therefore, on (b)(6) 2013, the doctor removed the reflexion implant from the patient's left great toe and noticed the implant was completely dislocated, with no contact between the two implants. The proximal implant came out fairly easily, and did not appear to have been placed using a cement product. The distal implant was more difficult to remove. It was sitting very plantar, and also did not appear to have been cemented into place. According to the ifu for the reflexion toe system, the device is intended for cemented use only. The x-rays were not available to us for review and the implants were not sent back to us for evaluation. Not having this information prevents us from determining the root cause for the complaint. As a note, it is stated in the ifu that the device is intended for cement fixation only. Based on the information provided there is a possibility that the surgeon who implanted the parts in 2010 may not have followed the ifu for using bone cement and the implant was not cemented in place. The name of the original doctor could not be obtained for follow up. There were no other similar complaints for these implants. Following removal, the surgeon performed a bone graft and fused the great toe using plates and screws. It was reported that the surgery went well.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2013-00002 |
| MDR Report Key | 3001315 |
| Report Source | 05,07 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-02-26 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2013-02-19 |
| Date Added to Maude | 2013-03-14 |
| 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 | GAIL SMITH |
| Manufacturer Street | 3885 ARAPAHO RD. |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774775 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METATARSAL HEAD LONG OR METATARSAL HEAL XLONG |
| Generic Name | REFLEXION |
| Product Code | LZJ |
| Date Received | 2013-03-05 |
| Catalog Number | 370-0205/370-0207 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-05 |