D
Patient 1
A SITE REPRESENTATIVE REPORTED THAT AN OPEN SPINE CLAMP HAS A BENT SCREW. THIS WAS NOT DISCOVERED DURING A CASE, THEREFORE, NO PT WAS PRESENT.
MAUDE MDR 2604147
- MDR report key
- 2604147
- Report number
- 1723170-2012-00290
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-05-15
- Date received
- 2012-06-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CYNTHIA CLAXON, SPECIALIST
- Address
- 826 COAL CREEK CIR. LOUISVILLE CO 80027 US
- Phone
- 770-770-7708
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPEN SPINE CLAMP, TITANIUM | STEREOTAXIC INSTRUMENT (HAW) | MEDTRONIC NAVIGATION, INC. | HAW | NA | 9731780 | 080718 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-06-06 | 0 |
Event Narratives#
N
Patient 1
NO PT WAS PRESENT AT THE TIME OF THE REPORT. RMA ISSUED. REPLACEMENT PART SHIPPED (B)(4) 2012. EVALUATION FINDS THE CLAMP FACE TO BENT TO ONE SIDE CAUSING TENSION ON THE ADJUSTMENT SCREW. THE RETAINER RING ON THE END OF THE ADJUSTMENT SCREW HAS ALSO BEEN STRETCHED ALLOWING SOME PLAY IN THE MOVEMENT OF THE CLAMP FACE.