MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-07-01 for BOX CHISEL 6541-4-709 manufactured by Stryker Orthopaedics-mahwah.
| Report Number | 0002249697-2019-02443 |
| MDR Report Key | 8749452 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-07-01 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-06-05 |
| Date Mfgr Received | 2019-08-23 |
| Device Manufacturer Date | 2004-09-02 |
| Date Added to Maude | 2019-07-01 |
| 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 | 3 |
| Manufacturer Contact | MR. JOANNE MAHONY |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NJ NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOX CHISEL |
| Generic Name | CHISEL, SURGICAL, MANUAL |
| Product Code | FZO |
| Date Received | 2019-07-01 |
| Returned To Mfg | 2019-06-11 |
| Catalog Number | 6541-4-709 |
| Lot Number | PYE10 |
| Device Expiration Date | 2009-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-01 |