MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Model Number 179702000 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/04/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Visual examination found that the initial threads on the set screw are torn.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the single inner setscrew cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.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 and no systemic trends were found, 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.
|
|
Event Description
|
It was reported that ,after final tightening of the single inner setscrew, the rod came out damaging the head of the poly screw and the single inner setscrew.Later 2 single inner setscrews were tried but that too got damaged.
|
|
Search Alerts/Recalls
|
|
|