MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Model Number 186715000 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problems
Unspecified Infection (1930); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The 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 on an unknown date, patient was in an accident in (b)(6) and taken to a swiss trauma center for a t12 compression fracture.Patient was instrumented percutaneously from t10-l2 using dss viper system.Upon return to the us, patient was bending and heard/felt a pop.He came to the er and images revealed the hardware had disassembled.Several set screws were displaced and the rod had come out of the screw saddle.During the revision surgery, it was found that all of the set screws were loose and some were sitting extremely proud in the screw saddle.Hardware was removed, replaced, and sufficiently locked.There was a patient consequence.Procedure outcome is unknown.This complaint involves eighteen (18) devices.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination of the setscrew revealed heavy signs of operative use as evidence by superficial markings.The set screw displays apparent damage consistent with tool marks inflicted during set screw removal.Weak rod striations were observed on the set screw suggesting that the set screw was not seated properly.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.A definitive root cause for the set screw becoming loose cannot be positively determined.However, the weak, rod striations observed on the set screw suggests that the set screw were not properly tightened on to the rod, resulting in the set screw becoming loose.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
|
|
|