MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-04-03 for CORE INTRA-ORAL BLADE 5400031034 manufactured by Stryker Ireland Ltd.
[1084466]
It was reported that during jaw surgery that two blades broke. It was further reported that no broken pieces were left behind in the patient. It was reported that the procedure was completed successfully with another blade.
Patient Sequence No: 1, Text Type: D, B5
[8433299]
The two blades subject to this mdr have two different lot numbers - 07088017 as listed in this report and also 07092017. The device manufacture date of the device with lot number 07092017 is 1st april 2007 and the expiration date is 1st april 2012. Once the returned device has been evaluated, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2009-00036 |
| MDR Report Key | 1417145 |
| Report Source | 07 |
| Date Received | 2009-04-03 |
| Date of Report | 2009-03-05 |
| Date of Event | 2009-03-04 |
| Date Mfgr Received | 2009-03-05 |
| Device Manufacturer Date | 2007-03-28 |
| Date Added to Maude | 2009-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MAIREAD TWOMEY |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CO.CORK |
| Manufacturer Country | EI |
| Manufacturer Phone | 214532988 |
| Manufacturer G1 | STRYKER IRELAND LTD |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CO.CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE INTRA-ORAL BLADE |
| Generic Name | SAW BLADES & ACCESSORIES |
| Product Code | DZH |
| Date Received | 2009-04-03 |
| Returned To Mfg | 2009-03-18 |
| Catalog Number | 5400031034 |
| Lot Number | 07088017 |
| Device Expiration Date | 2012-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER IRELAND LTD |
| Manufacturer Address | CARRIGTWOHILL, CO.CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-03 |