Catalog Number 211H6025 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
Deformity/ Disfigurement (2360)
|
Event Date 08/30/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
|
|
Event Description
|
It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report two of four for this event.
|
|
Manufacturer Narrative
|
If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2023-00319 through 3012447612-2023-00322.
|
|
Event Description
|
It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report two of four for this event.
|
|
Manufacturer Narrative
|
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be deleted.H6 additional investigation type code: 4109 and 4110.Inspection: an analyses confirmed the presence of frayed fibers and abrasive wear.Frayed fibers could be caused by normal use of the device, occur during removal, interaction with the screw and set screw, or during abnormal loading conditions.Further analysis utilized enzymatic cleaning to remove biological material from the specimen as confirmed by optical microscopy and atr-ftir.Atr-ftir showed that the spectrum of the cleaned cord was qualitatively nearly identical to that of an exemplar component, suggesting that the cord component has not experienced degradation.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
|
|
Event Description
|
It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report two of four for this event.
|
|
Search Alerts/Recalls
|