MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Model Number 179712735 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/02/2018 |
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
|
The l5 lumbar spondylolisthesis reconstruction surgery was performed with expedium si and hook system on (b)(6) 2018.It was reported that the surgeon could not apply the torque for final tightening the set screws.The surgeon confirmed there was no cross-threaded, so that the surgeon attempted to tighten couple of time, but the surgeon could not tighten the set screws.Then, the surgery was completed by replacing the screw which removed from the patient¿s lumbar.After the removing the screws, the surgeon recognized there was metal like fragment around the screw.There was 45min surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
|
|
Manufacturer Narrative
|
(b)(4).Visual examination found that the tulip head¿s threads were torn off.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 si polyaxial screw 7 x 35mm 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.
|
|
Manufacturer Narrative
|
(b)(4).Date of awareness for follow up # (b)(4) should have been 11/20/2018 not 11/2/2018.
|
|
Search Alerts/Recalls
|
|
|