MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-12-31 for TRINICA ANTERIOR CERVICAL PLATE SYSTEM 07.00796.001 07-00796.001 manufactured by Zimmer Spine, Inc..
[15502657]
While implanting the trinica plate and screws at c5-c7 a distal portion of the device broke off and lodged below the plate. The surgeon was able to remove the broken portion of the device. This added an additional 30 minutes to the surgery.
Patient Sequence No: 1, Text Type: D, B5
[15570904]
Device history records reviewed. Review of device history records indicate the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2008-00036 |
| MDR Report Key | 1302848 |
| Report Source | 07 |
| Date Received | 2008-12-31 |
| Date of Report | 2008-12-04 |
| Date of Event | 2008-12-02 |
| Date Mfgr Received | 2008-12-04 |
| Device Manufacturer Date | 2004-06-20 |
| Date Added to Maude | 2009-06-04 |
| 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 | ANNETTE DOXON |
| 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 ANTERIOR CERVICAL PLATE SYSTEM |
| Generic Name | TRINICA ATO SWIVEL ATO DRILL GUIDE |
| Product Code | HXY |
| Date Received | 2008-12-31 |
| Returned To Mfg | 2008-12-10 |
| Model Number | 07.00796.001 |
| Catalog Number | 07-00796.001 |
| Lot Number | P040129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE, INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-31 |