MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-01-21 for FLEXIBLE HUMERAL NAIL manufactured by Synthes (usa).
[17908493]
The surgeon complained that he could not remove the flexible humeral nail from the pt. The pt's fracture had healed, but the pt developed bursitis and experienced pain. During the procedure the surgeon had to enlarge the incision to dig around the implant and remove some bone. The attempted removal resulted in a fracture in the proximal lateral cortex of the bone. The nail remains in the pt and there are no further plans for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2004-00003 |
| MDR Report Key | 507364 |
| Report Source | 05,07 |
| Date Received | 2004-01-21 |
| Date of Report | 2004-01-08 |
| Date of Event | 2004-01-08 |
| Date Mfgr Received | 2004-01-08 |
| Date Added to Maude | 2004-01-23 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARYLYNNE GALLOWAY |
| Manufacturer Street | 1690 RUSSELL RD |
| Manufacturer City | PAOLI PA 19301 |
| Manufacturer Country | US |
| Manufacturer Postal | 19301 |
| Manufacturer Phone | 6106479700 |
| Manufacturer G1 | NI |
| Manufacturer Street | NI |
| Manufacturer City | NI |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE HUMERAL NAIL |
| Generic Name | FLEXIBLE NAILS |
| Product Code | KWJ |
| Date Received | 2004-01-21 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 496299 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL RD PAOLI PA 19301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-21 |