N
Patient 1
MAUDE MDR 6102534
- MDR report key
- 6102534
- Report number
- 6102534
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-30
- Date received
- 2016-11-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GARDNERER WELLS | ACCESSORIES, TRACTION | ZIMMER, INC. | ILZ | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-15 | 0 |
Event Narratives#
D
Patient 1
DURING A POSTERIOR CERVICAL FUSION PROCEDURE THE SURGEON REQUESTED GARDNER WELLS TRACTION TWINE TO 16 LBS. THE TWINE IS RATED FOR MUCH MORE WEIGHT. THIS WAS THE FIRST USE FOR THE TWINE. AT THE END OF THE PROCEDURE THE TWINE BROKE AND THE WEIGHTS FELL TO THE OPERATING ROOM FLOOR. NO KNOWN HARM TO PATIENT.