MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-07-17 for INTER-PHALANGEAL STERILE SURGICAL KIT 360-2240T 360-2200 manufactured by Osteomed.
[16987706]
The surgeon inadvertently implanted the trial of surgical kit 360-2200 instead of the actual implant (360-2240).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-2014-00008 |
| MDR Report Key | 3964868 |
| Report Source | 99 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-07-16 |
| Date of Event | 2014-06-17 |
| Date Mfgr Received | 2014-06-18 |
| Date Added to Maude | 2014-07-30 |
| 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 | LATOIA PHILLIPS |
| Manufacturer Street | 3885 ARAPAHO RD. |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774743 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTER-PHALANGEAL STERILE SURGICAL KIT |
| Generic Name | INTERPHLEX FLEXIBLE STABILITY RODS |
| Product Code | KWH |
| Date Received | 2014-07-17 |
| Model Number | 360-2240T |
| Catalog Number | 360-2200 |
| Lot Number | 1072754 |
| 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 |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-07-17 |