FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1822633
·
Received August 27, 2010
Report
- Report Number
- 1030489-2010-01109
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- August 2, 2010
- Report Date
- August 2, 2010
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- NKB
- PMA / PMN Number
- K051674
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INCISION ENLARGEMENT. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINI-INVASIVE SPINAL PROCEDURE AT L4-L5 USING POSTERIOR FIXATION. DURING THE PROCEDURE, THE ROD COULD NOT GET THROUGH L5 SCREW HEAD. REPORTEDLY, THE EXTENDER WAS APPLIED PROPERLY. THE UNILATERAL PROCEDURE WAS CHANGED TO OPEN PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | ROD INSERTER | NKB | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANT DATE:| ROD: |