MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-10-24 for SKELITE UNK * manufactured by Ebi, L.p..
[412442]
Approximately sixteen months ago md implanted bone graft material for a fracture. At the present time the graft material has not resorbed and pt had developed a nonunion.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2242816-2005-00047 |
MDR Report Key | 643068 |
Report Source | 05 |
Date Received | 2005-10-24 |
Date of Report | 2005-10-20 |
Date of Event | 2004-06-24 |
Date Mfgr Received | 2005-09-22 |
Date Added to Maude | 2005-10-28 |
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 | BARRY SANDS, VP |
Manufacturer Street | 100 INTERPACE PARKWAY |
Manufacturer City | PARSIPPANY NJ 07054 |
Manufacturer Country | US |
Manufacturer Postal | 07054 |
Manufacturer Phone | 9732999300 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SKELITE |
Generic Name | BONE SUBSTITUTE |
Product Code | LMN |
Date Received | 2005-10-24 |
Model Number | UNK |
Catalog Number | * |
Lot Number | UNK |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 632576 |
Manufacturer | EBI, L.P. |
Manufacturer Address | * PARSIPPANY NJ * US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2005-10-24 |