Catalog Number 211H6542 |
Device Problem
Unintended Movement (3026)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/19/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Product code: qhp.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.Reference reports 3012447612-2021-00287 through 3012447612-2021-00300.
|
|
Event Description
|
It was reported that a revision surgery was performed to remove a tether construct.The adult patient's curve was not improved as much as was hoped and there appeared to be a loss of correction sometime post-operatively.This is report twelve of fourteen for this event.
|
|
Event Description
|
It was reported that a revision surgery was performed to remove a tether construct.The adult patient's curve was not improved as much as was hoped and there appeared to be a loss of correction sometime post-operatively.This is report twelve of fourteen for this event.
|
|
Manufacturer Narrative
|
Inspection: the set screws and screws show evidence and minor damage to the threads that are indicative of use.Additionally, there is damage to the thread lead on one set screw that appears to be indicative of collision with another object, possibly during the removal process or subsequent cleaning, that prevents it from threading completely down into the tulip of the screw.There is no damage or wear that would point to a specific failure mode in-vivo.Dhr review: the lot number was not provided, so the dhr could not be reviewed.Potential root cause: the cause is attributed to off-label/contraindicated use since this device is approved for use on skeletally immature patients and contraindicated for skeletally mature patients; the patient is an adult.Device usage: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
|
|
Search Alerts/Recalls
|