MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-09-01 for SAWBLADE NEW Z STYLE 25WX050 6828-7-751 manufactured by Stryker Orthopaedics.
| Report Number | 2249697-2004-00109 |
| MDR Report Key | 950475 |
| Report Source | 07 |
| Date Received | 2004-09-01 |
| Date of Report | 2004-08-04 |
| Date of Event | 2004-08-04 |
| Date Mfgr Received | 2004-08-04 |
| Date Added to Maude | 2007-11-21 |
| 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 | JANICE PEVIDE |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAWBLADE NEW Z STYLE 25WX050 |
| Generic Name | INSTRUMENT |
| Product Code | DZH |
| Date Received | 2004-09-01 |
| Model Number | NA |
| Catalog Number | 6828-7-751 |
| Lot Number | 033463LO |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 921840 |
| Manufacturer | STRYKER ORTHOPAEDICS |
| Manufacturer Address | 325 CORPORATE DR. MAHWAH NJ 07430 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-01 |