MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-10-19 for SAGITTAL BLADE-STERNUM REVISION 2108137000 manufactured by Stryker Instruments-kalamazoo.
[28608386]
A follow up report will be filed once the quality investigation is complete. Device is not available for evaluation
Patient Sequence No: 1, Text Type: N, H10
[28608387]
It was reported that during a surgical procedure, the blade broke at the mount. It was further reported there was a delay of less than 30 minutes to obtain a replacement blade as a result of this event. It was also reported that there were no adverse consequences and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[32744885]
The quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[32744886]
It was reported that during a surgical procedure, the blade broke at the mount. It was further reported there was a delay of less than 30 minutes to obtain a replacement blade as a result of this event. It was also reported that there were no adverse consequences and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-03843 |
| MDR Report Key | 5159508 |
| Report Source | OTHER |
| Date Received | 2015-10-19 |
| Date of Report | 2015-09-23 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2015-11-30 |
| Date Added to Maude | 2015-10-19 |
| 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. DERVILLIA MURPHY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAGITTAL BLADE-STERNUM REVISION |
| Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
| Product Code | DWH |
| Date Received | 2015-10-19 |
| Catalog Number | 2108137000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-19 |