MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Model Number 199721000 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/21/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that - the head of the screw was disassembled when the alignment guide was introduced with a hammer for inserting the lock cap in a viper cortical fix fenestrated screw.The square threads of 2 verse correction keys were broken when they were inserted in the head of the screw.Was surgery delayed due to the reported event? no.Action taken when event occurred? to change the screw and the correction keys.Was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? yes.Patient status/ outcome / consequences? no.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? no.Is the patient part of a clinical study? no.(b)(4).Device property of: none.Device in possession of: none.
|
|
Manufacturer Narrative
|
Product complaint # = > (b)(4).Udi: (b)(4).The verse correction key was returned for evaluation.The poly lock subcomponent is missing a small part of the end of its outer threading.The rod lock subcomponent has a small nick on its top that has damaged its outer threading, as well as slight deformities about its upper threading.The inside of the rod lock is dented and warped in several places around its circumference.The subcomponents cannot be successfully reassembled.No other issues were identified with the returned portions.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer the complaint is confirmed.While the verse correction key¿s threading is worn, it is also stripped in a few areas.The rod lock subcomponent presents stripping and deformation.The deformation prevents the subcomponents from reassembling.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|