FDA Adverse Event
Malfunction
Summary report: N
APELO STANDARD REDUCTION HEAD
MDR report key: 1625290
·
Received March 3, 2010
Report
- Report Number
- 3003855635-2010-00004
- Event Type
- Malfunction
- Date Received
- March 3, 2010
- Date of Event
- January 25, 2010
- Report Date
- February 26, 2010
- Manufacturer
- ATLAS SPINE INC.
- Product Code
- KWQ
- PMA / PMN Number
- K072426
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOWING EXAMINATION OF THE DEVICE, IT WOULD APPEAR THE DAMAGE WAS LIKELY A DIRECT RESULT OF THE LOCKING RING ASSEMBLY BEING INCORRECTLY INSTALLED DURING PLACEMENT BY THE DOCTOR.
Description of Event or Problem · 1
DURING SURGERY, THE DOCTOR COULD NOT THREAD THE LOCKING COLLAR ON TO THE REDUCTION HEAD, DOCTOR REMOVED THE REDUCTION HEAD AND CONTINUED THE SURGERY WITH ANOTHER REDUCTION HEAD. SURGERY COMPLETED WITH NO FURTHER INCIDENT EXCEPT FOR DELAY OF APPROX A FEW SECONDS TO CHANGE THE REDUCTION HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APELO STANDARD REDUCTION HEAD | PEDICLE SCREW SYSTEM | KWQ | ATLAS SPINE INC. | 01129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |