MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-26 for GAIT 30 - 100 - 01 manufactured by Sgarlato Med Llc.
[21734759]
A sports doctor implanted a big toe joint into an infected bug toe in (b)(6) 2011. After several years of inflammation problems, the patient sought help at a wound care center. The wound care center sent the patient back to the sports doctor who removed the original implant and replaced it with an identical implant. The second surgery on the inflamed big toe took place on (b)(6) 2014. However, upon removal of the original implant, the doctor claims the implant had failed. Examination of the implant clearly shows that the implant was cut with a sharp instrument to remove it from the big toe. Examination by several other doctors confirmed that the sports doctor was responsible for the failure.
Patient Sequence No: 1, Text Type: D, B5
[22090326]
Report incident was received by the manufacturing site on (b)(4) 2014. Information was gathered and an evaluation made to determine seriousness of this incident. It was determined to be a 30 day notification. Starting (b)(4) /2014, the latest 3500a form was required, but after various attempts to get this form off the fda web page, none could be found or opened on the fda site. After a call to fda on (b)(4) 2014, an email address was provided to assist in contacting someone to obtain a latest copy of form 3500a. It was determined that the fda site was inoperative and forms could not be obtained. After query, a copy of the form was sent by email on 02/18/2014. Fortunately, the adverse event was not critical so is being submitted within the required time frame.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939320-2014-00001 |
| MDR Report Key | 3799690 |
| Report Source | 07 |
| Date Received | 2014-02-26 |
| Date of Report | 2014-02-23 |
| Date of Event | 2014-01-31 |
| Date Facility Aware | 2014-02-03 |
| Report Date | 2014-02-23 |
| Date Reported to FDA | 2014-02-25 |
| Date Reported to Mfgr | 2014-02-03 |
| Date Mfgr Received | 2014-02-03 |
| Date Added to Maude | 2014-07-17 |
| 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 | 3 |
| Manufacturer Contact | THOMAS LYPKA |
| Manufacturer Street | 1975 HAMILTON AVE. SUITE 38 |
| Manufacturer City | SAN JOSE CA 95125 |
| Manufacturer Country | US |
| Manufacturer Postal | 95125 |
| Manufacturer Phone | 4086269600 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAIT |
| Generic Name | GAIT |
| Product Code | KWH |
| Date Received | 2014-02-26 |
| Model Number | 30 - 100 - 01 |
| Catalog Number | 30 - 100 - 01 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SGARLATO MED LLC |
| Manufacturer Address | 1975 HAMILTON AVE. SUITE 38 SAN JOSE CA 95125 US 95125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-26 |