MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-25 for INTERPHLEX IPJ 360-2808 manufactured by Osteomed L.p..
[614909]
A male with hx of dislocated toe and hammertoe. Dr performed implant in 2004. In 2007, implant was removed because it had broken. Pt currently doing fine - not in pain. At time of surgery surgeon loosened tendons as required. No history of pt. Trauma to toe. Pt hammertoe reoccurred before explant - possibly due to pt's natural anatomy or the fact that more of a tendon lengthening/capsulotomy was needed at initial implantation.
Patient Sequence No: 1, Text Type: D, B5
[7959743]
During telephone call with dr. He stated that "post op the toe dislocated and took the stem with it, breaking implant. "
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2027754-2007-00005 |
MDR Report Key | 855604 |
Report Source | 05 |
Date Received | 2007-05-25 |
Date of Report | 2007-05-25 |
Date of Event | 2007-03-09 |
Date Added to Maude | 2007-06-01 |
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 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INTERPHLEX IPJ |
Generic Name | INTERPHALANGEAL SPACER |
Product Code | LZJ |
Date Received | 2007-05-25 |
Returned To Mfg | 2007-04-30 |
Model Number | 360-2808 |
Catalog Number | 360-2808 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | NA |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 841801 |
Manufacturer | OSTEOMED L.P. |
Manufacturer Address | ADDISON TX 75001 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2007-05-25 |