FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON LEGACY SPINAL SYSTEM
MDR report key: 1041216
·
Received May 8, 2008
Report
- Report Number
- 1030489-2008-00224
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 25, 2008
- Report Date
- April 11, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- K052187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SETSCREWS AND BONE SCREWS WERE RETURNED TO MEDTRONIC FOR EVAL. BOTH BONE SCREWS SHOW SIGNS OF HEAD SPLAY. FACE OF SETSCREWS SHOW SIGNS THAT PROPER REDUCTION OF ROD MAY NOT HAVE TAKEN PLACE. ONE SETSCREW SHOWS SIGNS OF POSSIBLE CROSSTHREADING. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THE THE SURGEON HAD DIFFICULTY LOCKING THE SETSCREWS INTO THE SCREW HEADS. THE SURGEON CHANGED THE SCREWS AND SETSCREWS AND COMPLETED THE CASE WITH NO FURTHER COMPLICATIONS. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON LEGACY SPINAL SYSTEM | SETSCREW | KWP | MEDTRONIC SOFAMOR DANEK | NA | H07L7303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |