FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1575546
·
Received December 17, 2009
Report
- Report Number
- 1030489-2009-01185
- Event Type
- Malfunction
- Date Received
- December 17, 2009
- Date of Event
- September 28, 2010
- Report Date
- April 20, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK MANUFACTURING
- Product Code
- KWP
- PMA / PMN Number
- K050809
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): THE SCREW REMAINS IMPLANTED. X-RAYS SHOWED A PEDICLE SCREW CONSTRUCT FROM L4 TO S1. THE SCREW AT L4 WAS BROKEN MID-PEDICLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT DECOMPRESSION FROM L4 TO S1, POSTERIOR LUMBAR FUSION (PLF) AT L4/L5 AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF/PLF) AT L5/S1. AT 15 MONTH POST OP VISIT, X-RAYS SHOWED THAT THE L4 SCREW BROKE AT THE BONE-SCREW INTERFACE. THE PT WAS NOT EXPERIENCING PAIN. REVISION SURGERY IS NOT PLANNED AT THIS TIME. NO FURTHER PT COMPLICATIONS WERE REPORTED.
Description of Event or Problem · 1
THE PATIENT UNDERWENT REVISION SURGERY 25 MONTHS POST-OP TO HAVE THE BROKEN SCREW AND ROD REPLACED. IN ADDITION, A INTERBODY FUSION WAS PERFORMED AT L4-L5. FUSION OCCURRED AT L5-S1. NO PATIENT COMPLICAITONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | SCREW | KWP | MEDTRONIC SOFAMOR DANEK MANUFACTURING | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | IMPLANTED:| IMPLANTED:| IMPLANTED:| ROD: CATALOG # UNK, LOT # UNK| EXPLANTED:| SET SCREW: CATALOG # UNK, LOT # UNK| INTERBODY: CATALOG # UNK, LOT # UNK| EXPLANTED:| EXPLANTED: |