ERISMA-LP
Received Dec 11, 2018 · Event occurred Jul 30, 2018
Report 3008992889-2018-00002 · MDR key 8149919
Device
Generic name
Pedicle Screw
Manufacturer
Clariance SasModel number
18176550Catalog number
18176550
Lot number
I265X
Product problems
- Off-Label Use
- Off-Label Use
Patient
60 YR
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
THE PEDICLE SCREW INVOLVED IN THIS FIXATION FAILURE, AS WELL AS THE SET SCREW LOOSENED, HAVE BEEN EXAMINED TO CHECK IF THEY HAVE BEEN DEGRADED DURING THE CONSTRUCT TIGHTENING. THE DIMENSIONAL ANALYSIS CONDUCTED DEMONSTRATES THAT BOTH PEDICLE SCREW AND SET SCREW ARE IN CONFORMITY WITH THE SPECIFICATIONS OF THE TECHNICAL DRAWINGS. THE VISUAL EXAMINATION DOES NOT INDICATE ANY ABNORMAL SURFACE ISSUE OR MATERIAL ISSUE.
Description of Event or Problem
TWO WEEKS POST-OP ON A T10-L3 FUSION CONSTRUCT FOR VERTEBRAL FRACTURE TREATMENT, THE PEDICLE SCREW ON CONTRA-LATERAL SIDE WAS PULLED OUT OF PEDICLE. AS A CONSEQUENCE, THE SET SCREW LOOSENED. THE PATIENT NEEDED A REVISION SURGERY TO RESECURE THE CONSTRUCT. THE CONSTRUCT WAS LENGTHENED TO L4 AND PEDICLE SCREWS WHICH PULLED OUT WERE REPLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.
Remedial action
- Replace
- Patient Monitoring