MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-07-12 for TRINICA DRILL GUIDE, ALL THROUGH ONE 07.00796.001 manufactured by Zimmer Spine.
[1602462]
During surgery to implant a cervical plate, the alignment post broke off the drill guide while the surgeon was implanting screws. The broken piece was removed with no difficulty and the surgery continued.
Patient Sequence No: 1, Text Type: D, B5
[8608032]
Additional information will be provided when the device evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184052-2010-00022 |
| MDR Report Key | 1756615 |
| Report Source | 08 |
| Date Received | 2010-07-12 |
| Date of Report | 2010-06-14 |
| Date of Event | 2010-06-14 |
| Date Mfgr Received | 2010-06-14 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2011-02-03 |
| 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 ROAD |
| Manufacturer City | MINNEAPOLIS MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528325600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINICA DRILL GUIDE, ALL THROUGH ONE |
| Product Code | HXY |
| Date Received | 2010-07-12 |
| Returned To Mfg | 2010-06-18 |
| Model Number | 07.00796.001 |
| Catalog Number | 07.00796.001 |
| Lot Number | P040129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | 7375 BUSH LAKE ROAD MINNEAPOLIS MN 55439 US 55439 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-12 |