Catalog Number 54850017545 |
Device Problem
Metal Shedding Debris (1804)
|
Patient Problem
Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that on an unknown date, post-op, patient presented to surgeon with pain.Bone scan completed and showed hot spots at l3 and s1.Surgeon decided to reoperate and replace the screw in revision surgery.During removal, surgeon noticed a large amount of metallosis on the left l3 level.
|
|
Manufacturer Narrative
|
Product analysis: the bone screw saddle has witness marks across the face.There are also witness marks on the side of the screw head from off axis pressure.The witness marks align with the witness marks on the rod.Conclusion:the root cause of the one set screw backing out is consistent with angle of the rod in respect to the saddle of the bone screw.This allowed the rod to move inside the bone screw head, removing material from the set screw.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|