D
Patient 1
SURGEON WAS DRILLING WITH THE DRILL GUIDE WITH GRADUATION AND THE SLEEVE KEPT PUSHING DOWN DURING CERVICAL THORACIC FUSION. SURGEON NOTICED THAT THE LATCH WAS LOOSE. SURGEON COMPLETED THE PROCEDURE BY KEEPING HIS THUMB ON THE SLEEVE.
MAUDE MDR 1804895
- MDR report key
- 1804895
- Report number
- 1719045-2010-00199
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-03-18
- Date received
- 2010-08-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LINDA HENDRIXSON
- Address
- 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DRILL GUIDE WITH GRADUATION | DRILL GUIDE | SYNTHES MONUMENT | LXI | NA | 388.393 | 575299F07 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-08-05 | 0 |
Event Narratives#
N
Patient 1
INFORMATION INITIALLY REPORTED TO SYNTHES ON (B)(6) 2008 AND WAS DETERMINED TO BE NOT REPORTABLE. ON (B)(6) 2010, SYNTHES PERFORMED A COMPLAINT HISTORY REVIEW AND UPDATED THE COMPLAINT TO REPORTABLE BASED ON THE COMPLAINT TREND. DATE OF THIS REPORT BASED ON THE DATE OF THE COMPLAINT HISTORY REVIEW. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS LOT AND NO COMPLAINT RELATED ANOMALIES WERE FOUND. THE STEM ASSEMBLY WAS CONFIRMED TO BE SLIPPING. DURING INVESTIGATION, IT WAS FOUND THAT THE DETENT AND THE PLUNGER SPRINGS WERE UNDERSIZED. IT WAS ALSO FOUND THAT THE DETENT AND PLUNGER SPRINGS WERE SWAPPED IN POSITION FROM THE MANUFACTURING SPECIFICATIONS. AS A RESULT, A CORRECTIVE ACTION WAS OPENED TO UPDATE THE DETAILED ASSEMBLY INSTRUCTIONS.