MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-07-28 for TRINICA ATO 07.00784.001 manufactured by Zimmer Spine, Inc..
[1240050]
During surgery, the fixation post feature detached from the device and embedded itself in the cervical plate. The post was retrieved after all the screws were fully inserted into the plate. Surgery was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
[8372660]
Device history record reviewed. Review of device history records indicate the device was manufactured to specification. This mdr is being submitted late as this issue was identified during a retrospective review of complaint files conducted in-conjunction with implementation of revised mdr reporting criteria for zimmer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2009-00032 |
| MDR Report Key | 1485837 |
| Report Source | 07 |
| Date Received | 2009-07-28 |
| Date of Report | 2006-07-26 |
| Date of Event | 2006-07-26 |
| Date Mfgr Received | 2006-07-26 |
| Device Manufacturer Date | 2006-03-02 |
| Date Added to Maude | 2010-06-08 |
| 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 | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE RD. |
| Manufacturer City | MINNEAPOLIS MN 554392027 |
| Manufacturer Country | US |
| Manufacturer Postal | 554392027 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINICA ATO |
| Generic Name | FIXED DOUBLE BARREL DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2009-07-28 |
| Returned To Mfg | 2006-08-01 |
| Model Number | 07.00784.001 |
| Catalog Number | 07.00784.001 |
| Lot Number | P051206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE, INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-28 |