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..
[428727]
Approximately fourteen months ago md implanted bone graft material for a fracture. At the present time the graft material has not resorbed and patient has developed a nonunion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-2005-00045 |
| MDR Report Key | 643090 |
| Report Source | 05 |
| Date Received | 2005-10-24 |
| Date of Report | 2005-10-20 |
| Date of Event | 2004-04-21 |
| 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 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HIGHWAY, 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653259 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2597 |
| 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 | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 632598 |
| Manufacturer | EBI, L.P. |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-10-24 |