MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-08 for NORIAN DRILLABLE 10 CC SRS-1000-FRI manufactured by Synthes Norian.
[3457901]
It was reported that the cement cannot be filled into the syringe. No further information was provided. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[3893773]
It was reported that after mixing in the rotation mixer, the cement could not be filled into the syringe and it hardened.
Patient Sequence No: 1, Text Type: D, B5
[10804137]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. The device listed in this report is used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Actual event date not known. Device is not distributed in the united states, but is similar to device marketed in the usa. The mixing system was returned to us and we have forwarded the article in question to our product manager in charge for further analysis. Unfortunately, we cannot reproduce the exact reason for the problem that appeared. In the pouch, an evenly distributed cement is visible which indicates that the mixing process was in order. We can only surmise that the transfer process of the mixer had been defective. A review of the device history records has been requested. Conclusion? Subject device has been received and is currently in the evaluation process. Investigation is ongoing; we are unable to give a conclusive statement regarding a possible failure reason and currently the complaint condition is due to an unknown cause.
Patient Sequence No: 1, Text Type: N, H10
[10914645]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Manufacturing documents were reviewed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[25394789]
Added part expiration date of 03/31/2012. (b)(4). Blank fields on this form indicate information that is unknown, unavailable or unchanged.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939274-2013-00010 |
| MDR Report Key | 3156863 |
| Report Source | 01,07 |
| Date Received | 2013-06-08 |
| Date of Report | 2011-07-13 |
| Date Mfgr Received | 2013-07-12 |
| Device Manufacturer Date | 2010-03-31 |
| Date Added to Maude | 2013-09-04 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES NORIAN |
| Manufacturer Street | 1230 WILSON DRIVE |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NORIAN DRILLABLE 10 CC |
| Product Code | OIS |
| Date Received | 2013-06-08 |
| Catalog Number | SRS-1000-FRI |
| Lot Number | N998500 |
| Device Expiration Date | 2012-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES NORIAN |
| Manufacturer Address | 1230 WILSON DRIVE WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-08 |